US Market News
2週前
Hyperfine to Join Russell 2000® and Russell 3000® IndexesMay 26, 2026 8:15 AM
Business Wire Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system— today announced that Hyperfine is expected to join the broad-market Russell 3000® Index and the small-cap Russell 2000® Index at the conclusion of the June 2026 Russell Reconstitution, according to a preliminary list of additions posted by FTSE Russell on May 22, 2026. Hyperfine's inclusion will become effective after the U.S. market close on June 26, 2026. The June reconstitution of the Russell US indexes captures up to the 4,000 largest U.S. stocks as of April 30, ranking them by total market capitalization. Membership in the Russell 3000® Index, which remains in place for six months under the semi-annual reconstitution schedule beginning in 2026, means automatic inclusion in the large-cap Russell 1000® Index or small-cap Russell 2000® Index as well as the appropriate growth and value style indexes. FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes. “We are pleased that Hyperfine is expected to join the Russell 3000 and Russell 2000 Indexes as part of the June 2026 reconstitution,” said Maria Sainz, President and Chief Executive Officer of Hyperfine. “We believe this inclusion reflects the continued progress in executing our commercial strategy, broadening awareness and driving adoption of our portable MRI technology and creating long-term value for shareholders.” Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. According to data as of the end of June 2025, about $12.2 trillion in assets are benchmarked against the Russell US indexes, which belong to FTSE Russell, the global index provider. About the Swoop® Portable MRI Systems
The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. About Hyperfine, Inc.
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit HyperfineMRI.com. Hyperfine, the Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine. Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy, including its entrance into new markets. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to progress on product advancements and improvements; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. View source version on businesswire.com: https://www.businesswire.com/news/home/20260526952799/en/ Media Contact
Devin Zell
Hyperfine
dzell@hyperfine.io Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com Original: Hyperfine to Join Russell 2000® and Russell 3000® Indexes
US Market News
2週前
Hyperfine Announces Presentation of Results from the PRIME Study Showing Portable MRI Substantially Reduces Time to Imaging in Emergency DepartmentsMay 22, 2026 8:15 AM
Business Wire Prospective randomized ED study shows rapid bedside imaging, detection of critical neurological findings, and potential workflow efficiency benefits with portable MRI Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced the presentation of results of the PRIME (Portable Rapid Imaging for Medical Emergencies) study at the Society for Academic Emergency Medicine (SAEM) 2026 Annual Meeting. PRIME is a single-center, prospective, randomized controlled trial designed to evaluate the role of portable MRI in neurological emergencies in the emergency department (ED), including the technology’s potential effectiveness and efficiency in supporting triage decisions for a wide range of brain-related emergency medical conditions. Conducted at a tertiary emergency department, the study enrolled 100 participants and compared standard clinical workflow using conventional MRI, along with a care pathway that incorporated a portable MRI system at the patient’s bedside. Results presented at SAEM demonstrate a significant reduction in time to imaging for patients randomized to the portable MRI arm. Median time from imaging order to scan start was 1.28 hours in the portable MRI group, compared with 7.76 hours in the conventional MRI only control arm—a median difference of 6.35 hours. 18.6% of the scans completed revealed critical pathology, including acute ischemic stroke, mass lesions, mass effect, and hydrocephalus, all of which were successfully detected by portable MRI and confirmed on conventional MRI. “These findings suggest that portable MRI can be integrated into emergency department workflow far more quickly than conventional MRI and can provide clinically meaningful information when time matters most,” said Dr. Charles Wira, Associate Professor of Emergency Medicine at Yale University. “By bringing advanced imaging to the bedside, portable MRI has the potential to improve diagnostic efficiency, reduce delays, and support faster treatment decisions for patients with neurological emergencies.” “Portable MRI also has the potential to meaningfully reduce emergency department boarding by helping to alleviate delays associated with waiting for access to conventional MRI,” said Dr. Kevin Sheth, Professor of Neurology and Neurosurgery at the Yale School of Medicine and principal investigator for the PRIME study. “Reducing imaging-related bottlenecks may help ED teams move patients through care pathways more efficiently while maintaining access to advanced neuroimaging.” The PRIME study builds on prior research evaluating portable MRI in emergency settings and expands the evidence base by studying a broader emergency department population. PRIME was conducted using the Hyperfine Model 2 Swoop® portable MRI system powered by Optive AI™ software, which is designed to deliver sharper anatomical detail and support broader use of portable brain imaging across emergency care environments. “Enrollment in PRIME was very fast, signaling how frequently MRI is needed as a triage tool in the ED. The presentation of these data at SAEM represents an important milestone for Hyperfine and for the future of emergency neuroimaging,” said Maria Sainz, President and CEO of Hyperfine. “We believe these results reinforce the potential for portable MRI to help clinicians access actionable imaging information sooner, improve emergency department workflows for ruling in and ruling out pathology, and expand access to advanced brain imaging where conventional MRI remains difficult to obtain.” Hyperfine is committed to advancing the role of portable MRI in emergency care, where timely access to conventional MRI remains a challenge for many hospitals. The PRIME study adds to a growing body of evidence supporting portable MRI as an efficient adjunct to emergency neuroimaging and underscores its potential to reduce diagnostic delays and improve patient care at the point of care. For more information about the Swoop® system, please visit HyperfineMRI.com. About the Swoop® AI-Powered Portable MRI Systems The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. About Hyperfine, Inc. Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit HyperfineMRI.com. Hyperfine, the Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy, including its entrance into new markets. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop ® system is accepted and used by healthcare professionals; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future ; the inability of the Company to progress on product advancements and improvements ; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. View source version on businesswire.com: https://www.businesswire.com/news/home/20260522721021/en/ Media Contact
Devin Zell
Hyperfine
dzell@hyperfine.io Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com Original: Hyperfine Announces Presentation of Results from the PRIME Study Showing Portable MRI Substantially Reduces Time to Imaging in Emergency Departments
US Market News
4週前
Hyperfine, Inc. Reports First Quarter 2026 Financial ResultsMay 12, 2026 4:05 PM
Business Wire Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced first quarter 2026 financial results and provided a business update. “Our execution in Q1 was strong. We delivered our second-highest revenue quarter to date with over 80% year-over-year revenue growth, driven by our accelerating commercial engine. We believe the international regulatory clearances we secured, the clinical data we released to the neurology and stroke communities, and the continued momentum in our office and hospital businesses all indicate portable brain MRI is becoming mainstream, and we are leading the charge,” said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. Recent Achievements and Business Highlights Obtained CE Marking and UK Conformity Assessment (UKCA) approval for both the next-generation Swoop® system and the latest Optive AI™ software in Europe. Enrolled first patient in Contrast PMR, a study designed to support a future FDA 510(k) submission to expand the Swoop® system’s intended use to include gadolinium-based contrast agents; enrollment currently is over 50% of target. Presented NEURO-PMR results at the 2026 American Society of Neuroimaging showing high diagnostic value and superior patient experience in neurology clinics. Published paper in Stroke: Vascular and Interventional Neurology (SVIN) demonstrating the Swoop® system’s enhanced stroke detection capabilities. Published paper in Clinical Neuroimaging demonstrating the significant health economic benefit of using the Swoop® system. Began launch activities in India market with first Swoop® system live in clinical use at All India Institute of Medical Sciences (AIIMS), New Delhi. Bolstered balance sheet through $15.0 million debt financing, extending the expected cash runway into 2028, and providing capital for commercial growth. First Quarter 2026 Financial Results Revenues for the first quarter of 2026 were $3.90 million, increasing 83% compared to $2.14 million in the first quarter of 2025. Sold 10 commercial Swoop® systems in the first quarter of 2026, compared to six in the first quarter of 2025. Gross profit for the first quarter of 2026 was $1.98 million, compared to $0.88 million in the first quarter of 2025, representing 51% gross margin in the first quarter of 2026, compared to 41% gross margin in the first quarter of 2025. Research and development expenses for the first quarter of 2026 were $3.85 million, decreasing 24% compared to $5.04 million in the first quarter of 2025. Sales, marketing, general, and administrative expenses for the first quarter of 2026 were $6.69 million, compared to $6.75 million in the first quarter of 2025. Net loss for the first quarter of 2026 was $8.62 million, equating to a net loss of $0.09 per share, as compared to a net loss of $9.42 million, or a net loss of $0.12 per share, for the first quarter of 2025. The first quarter of 2026 net loss includes a $0.24 million loss from a change in the fair value of warrant liabilities, compared to a $1.62 million gain in the first quarter of 2025. 2026 Financial Guidance Management continues to expect revenue for the full year 2026 to be approximately $20 to $22 million, representing 55% growth at the midpoint as compared to full year 2025. Management continues to expect cash burn1 for the full year 2026 to be approximately $26 to $28 million, representing a 10% decline at the midpoint as compared to full year 2025. 1Cash burn is calculated as change in cash and cash equivalents less net financing proceeds. Conference Call Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Tuesday, May 12, 2026 to discuss its first quarter 2026 financial results and provide a business update. Those interested in listening should register online by visiting https://investors.hyperfine.io/ and clicking on News & Events. Participants are encouraged to register more than 15 minutes before the start of the call. A live and archived audio webcast will be available through the Investors page of Hyperfine, Inc.’s corporate website at https://investors.hyperfine.io/. About Hyperfine, Inc. and the Swoop® Portable MR Imaging® Systems Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first U.S. Food and Drug Administration (FDA)-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit hyperfine.io. The Swoop® Portable MR Imaging® systems are FDA cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop® system also has CE Mark in the European Union and UKCA Mark in the United Kingdom. The Swoop® system is commercially available in a select number of international markets. Hyperfine, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations about the Company’s financial and operating results, including, the Company’s expected revenue and cash burn for the full year 2026, the Company's cash runway, the Company’s goals and commercial plans, including the Company’s commercial rollout of the Company’s Optive AITM software and next generation Swoop® system, the acceleration of the adoption of the Swoop® system across multiple sites of care in the hospital, neurology office and international markets, the benefits of the Company’s products and services, progress on improvements and advancements in the Company’s products and services, and the Company’s future performance, including its financial performance, and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the Company’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the ability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the ability of the Company to identify, in-license or acquire additional technology; the ability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; the ability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; the Company’s ability to successfully complete and generate positive data from the PRIME study, ACTION PMR study, Contrast PMR study, CARE PMR study and NEURO PMR study; the Company’s ability to generate clinical evidence of the benefits of the Company’s products and services and to progress on product advancements and improvements; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based. HYPERFINE, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands, except share and per share amounts) (Unaudited) March 31,
2026 December 31,
2025 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 40,778 $ 35,085 Restricted cash 500 957 Accounts receivable, less allowance of $534 and $1,372 as of March 31, 2026 and December 31, 2025, respectively 3,791 5,254 Unbilled receivables 2,006 1,268 Inventories 6,327 7,090 Prepaid expenses and other current assets 2,631 1,255 Property and equipment, net 56,033 50,909 Other long term assets 2,503 2,549 Total assets 1,803 1,804 LIABILITIES AND STOCKHOLDERS’ EQUITY $ 60,339 $ 55,262 CURRENT LIABILITIES: Accounts payable $ 4,552 $ 4,051 Deferred grant funding 500 957 Deferred revenue 1,578 1,544 Due to related parties 56 50 Accrued expenses and other current liabilities 3,468 5,130 Total current liabilities 10,154 11,732 Long-term debt, net 13,123 — Warrant liabilities 1,971 1,730 Long term deferred revenue 713 729 Other noncurrent liabilities 17 66 Total liabilities 25,978 14,257 STOCKHOLDERS' EQUITY Class A Common stock, $0.0001 par value per share; 600,000,000 shares authorized; 83,464,909 and 82,166,458 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively 8 8 Class B Common stock, $0.0001 par value per share; 27,000,000 shares authorized; 15,055,288 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively 2 2 Additional paid-in capital 372,990 371,011 Accumulated deficit (338,639 ) (330,016 ) Total stockholders' equity 34,361 41,005 TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 60,339 $ 55,262 HYPERFINE, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS (in thousands, except share and per share amounts) (Unaudited) Three Months Ended
March 31, 2026 2025 Sales Device $ 3,257 $ 1,522 Service 646 615 Total sales $ 3,903 $ 2,137 Cost of sales Device $ 1,646 $ 985 Service 278 269 Total cost of sales $ 1,924 $ 1,254 Gross profit 1,979 883 Operating Expenses: Research and development $ 3,845 $ 5,037 General and administrative 4,130 4,208 Sales and marketing 2,562 2,540 Total operating expenses $ 10,537 $ 11,785 Loss from operations $ (8,558 ) $ (10,902 ) Interest income $ 254 $ 317 Interest expense (83 ) — Change in fair value of warrant liabilities (241 ) 1,618 Other income (expense), net 5 (451 ) Loss before provision for income taxes $ (8,623 ) $ (9,418 ) Provision for income taxes — — Net loss and comprehensive loss $ (8,623 ) $ (9,418 ) Net loss per common share attributable to common stockholders, basic and diluted $ (0.09 ) $ (0.12 ) Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted 97,695,133 75,697,199 HYPERFINE, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS (in thousands) (Unaudited) Three Months Ended March 31, 2026 2025 Cash flows from operating activities: Net loss $ (8,623 ) $ (9,418 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation 274 229 Stock-based compensation expense 647 945 Loss on disposal of property and equipment, net 5 — Change in fair value of warrant liabilities 241 (1,618 ) Amortization of debt discount and issuance costs 17 — Other 6 11 Changes in assets and liabilities: Accounts receivable, net 1,463 626 Unbilled receivables (738 ) 412 Inventory 763 1,193 Prepaid expenses and other current assets (1,401 ) (1,241 ) Other long term assets (69 ) 128 Accounts payable 504 600 Deferred grant funding (457 ) 413 Deferred revenue 18 (80 ) Due to related parties 6 (7 ) Accrued expenses and other current liabilities (1,667 ) (1,435 ) Operating lease liabilities, net 3 (7 ) Net cash used in operating activities $ (9,008 ) $ (9,249 ) Cash flows from investing activities: Purchases of property and equipment (242 ) (472 ) Net cash used in investing activities $ (242 ) $ (472 ) Cash flows from financing activities: Proceeds from issuance of debt, net $ 13,641 $ — Proceeds from exercise of stock options 42 33 Proceeds from issuance of Class A common stock under “at-the-market” offering program, net 803 129 Proceeds from issuance of Class A common stock with warrants under February 2025 Offering, net — 5,420 Net cash provided by financing activities $ 14,486 $ 5,582 Net increase (decrease) in cash and cash equivalents and restricted cash 5,236 (4,139 ) Cash, cash equivalents and restricted cash, beginning of period 36,042 37,673 Cash, cash equivalents and restricted cash, end of period $ 41,278 $ 33,534 Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets Cash and cash equivalents $ 40,778 $ 33,093 Restricted cash 500 441 Total cash, cash equivalents and restricted cash $ 41,278 $ 33,534 Supplemental disclosure of noncash information: Issuance of warrants in connection with Loan Agreement, net $ 495 $ — Initial measurement of warrant liabilities $ — $ 2,858 Unpaid purchase of property and equipment $ 28 $ 509 Unpaid debt issuance and financing costs $ 15 $ 238 View source version on businesswire.com: https://www.businesswire.com/news/home/20260512320170/en/ Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com Original: Hyperfine, Inc. Reports First Quarter 2026 Financial Results
US Market News
1月前
Hyperfine Swoop® System Introduced as India’s First Portable MRI for Bedside Brain Imaging at the Country’s Leading Medical InstitutionApril 29, 2026 8:15 AM
Business Wire
The All India Institute of Medical Sciences, New Delhi, in partnership with Radiosurgery Global India, begins clinical use of the Hyperfine Swoop® portable MRI system
Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—and the All India Institute of Medical Sciences (AIIMS), New Delhi, India's foremost medical institution, today announced that AIIMS New Delhi has initiated clinical use of the Swoop® portable MRI system. AIIMS New Delhi is the first hospital in India to deploy bedside MRI for routine clinical use, marking an important milestone for neurological care across the country.
In a collaboration between Radiosurgery Global Ltd. (the exclusive Swoop® system distributor in India) and AIIMS New Delhi's Centre for Neurological Conditions, the Swoop® system is now performing bedside brain imaging for routine clinical care under the leadership of Dr. Shailesh Gaikwad, Head of the Department of Neuroimaging and Interventional Neuroradiology and Chief of the Neuroscience Centre at AIIMS New Delhi.
“Bedside brain imaging transforms how we care for our most critically ill patients. At AIIMS, we manage thousands of stroke and ICU patients annually, where rapid neuroimaging is essential—yet transport to conventional MRI is often unsafe or impossible. The Swoop® system eliminates that barrier. Now our clinicians can obtain diagnostic images at the point of care, enabling faster decision-making in neurology, trauma, and critical care. For a medical institution like ours that serves as a referral center across India, this deployment signals what's possible when technology and clinical need align to advance neurological care,” said Dr. Shailesh Gaikwad, Head, Department of Neuroimaging and Interventional Neuroradiology and Chief of Neuroscience Centre AIIMS New Delhi.
Why This Matters for India
India is home to over a billion people across diverse geographies, including urban megacities, remote districts, rural communities, and everything in between. Across this landscape, timely access to neuroimaging remains a significant challenge. When patients suffer a stroke, sustain a brain injury, or present with a neurological emergency, the imaging required for diagnosis and treatment is often delayed or unavailable.
Conventional high-field MRI systems require dedicated shielded rooms, specialized infrastructure, and patient transport. For critically ill patients in ICUs, trauma bays, neurosurgery wards, neonatal units, and emergency departments, transport is often not feasible. These limitations can delay diagnosis and treatment and impact outcomes.
The Swoop® system addresses these barriers by bringing MRI directly to the point of care. It requires no dedicated room, specialized power, or patient transfer. Clinicians can roll the system to the patient’s bedside in the ICU, trauma center, stroke unit, or neonatal ward and obtain brain images when and where they are needed most.
The Breadth of Clinical Impact
The Swoop® system supports a wide range of unmet clinical needs across India’s healthcare ecosystem:
Neurology and Stroke: Rapid bedside brain imaging to support timely assessment and decision-making in acute stroke care without the risks associated with patient transfer.
Emergency Care and Trauma: Timely bedside assessment of traumatic brain injury in clinical settings where speed of diagnosis is critical.
Critical Care and ICU: Ongoing neurological monitoring for critically ill patients without disrupting intensive care workflows.
Pediatric Care: Safe, accessible brain imaging for infants in PICUs, where conventional MRI is often inaccessible or clinically impractical.
Outpatient Neurology and GP Practices: Community-based point-of-care brain imaging that supports screening and streamlined referral pathways.
Neurosurgery: Post-operative monitoring without moving vulnerable patients.
Deployment at AIIMS New Delhi marks the beginning of broader adoption across India, bringing point-of-care brain imaging to clinical environments where it can have the greatest impact.
“Bringing the Swoop® system to AIIMS New Delhi is an important milestone following regulatory approval last December. India has a significant unmet need for accessible brain imaging. Deployment at the country’s leading institution signals the start of bringing point-of-care brain MRI to sites of care and institutions across India, where it can serve clinicians and their patients across neurological conditions,” said Maria Sainz, President and CEO of Hyperfine.
“Radiosurgery Global exists to democratize access to transformative technologies. We're proud that the Swoop® system's first clinical deployment in India is at AIIMS New Delhi—an institution that shares our commitment to advancing patient care across this vast, underserved landscape. This isn't just a regulatory or commercial milestone—it's the beginning of changing outcomes for critically ill patients in ICUs, trauma units, and stroke centers nationwide,” said Kapil Kalra, Managing Director, Radiosurgery Global Ltd.
A Platform for Clinical Research and Discovery
The Swoop® system deployment at AIIMS New Delhi also establishes a foundation for clinical research. As a leading center for neuroscience research and clinical innovation, AIIMS New Delhi is uniquely positioned to generate real-world evidence to guide the adoption and utilization of portable MRI across India. The AIIMS New Delhi team plans to document outcomes, contribute to peer-reviewed publications, and advance India’s role in the growing global evidence base for point-of-care brain imaging.
For more information about the Swoop® system, please visit HyperfineMRI.com.
About the Swoop® Portable MRI Systems
The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
About Hyperfine, Inc.
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit HyperfineMRI.com.
About AIIMS New Delhi
The All India Institute of Medical Sciences (AIIMS), New Delhi, established in 1956, is India's premier autonomous public medical university and national referral center for tertiary healthcare, medical education, and biomedical research. AIIMS New Delhi consistently ranks as the number one hospital in India and trains thousands of specialists who go on to shape clinical practice nationwide. The Centre for Neurological Conditions (CNC) at AIIMS New Delhi is one of India's foremost centers for neurological care, research, and innovation.
About Radiosurgery Global Ltd.
Radiosurgery Global Ltd. (RSG), operating through its Indian entity Jona Tech Systems Pvt. Ltd., is the exclusive authorized distributor of the Hyperfine Swoop® system across India. RSG is a vertically integrated advanced medical technology company headquartered in London with offices in New Delhi, Munich, Dubai, Singapore, Jakarta, and Sydney, focused on driving innovative technologies into high-growth markets and expanding patient access to world-class diagnostics.
Hyperfine, the Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy, including its entrance into new markets. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the inability to maintain the listing of the Company’s Class A common stock on the Nasdaq Stock Market; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to progress on product advancements and improvements; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; anticipated National Institutes of Health funding pressures; the effect of U.S. export controls and tariffs; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260429706357/en/
Media
Devin Zell
Hyperfine
dzell@hyperfine.io
Investor
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com
Original: Hyperfine Swoop® System Introduced as India’s First Portable MRI for Bedside Brain Imaging at the Country’s Leading Medical Institution
US Market News
2月前
Hyperfine Receives CE and UKCA Marks for Next-Generation Swoop® System and Latest Advancement in Optive AI™ SoftwareApril 9, 2026 8:15 AM
Business Wire
This milestone unlocks Hyperfine’s most significant technology innovations to date for clinicians and patients across Europe and the United Kingdom, delivering a transformative leap in image quality and a major expansion of clinical capability for European markets
Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced it has received CE Marking and UK Conformity Assessment (UKCA) approval for both the next-generation Swoop® system and the latest advancement in its Optive AI™ software. Together, these regulatory approvals enable commercialization of Hyperfine’s most advanced portable MRI technology across Europe and the United Kingdom (UK), expanding access to high-quality brain imaging at the point of care and representing a pivotal milestone in the company’s international commercial growth strategy.
The next-generation Swoop® scanner, which was cleared by the FDA in the second quarter of 2025, represents a significant advancement in portable brain MRI, delivering substantial improvements in image quality, workflow, and overall user experience. The next-generation Swoop® system has generated strong customer interest in the US market, where Hyperfine has placed systems in critical care and emergency rooms of hospitals, as well as in neurology offices.
In addition, Hyperfine received European approvals for the latest advancement in its Optive AI™ software, which was cleared by the FDA in December 2025. The new software includes a new multi-direction diffusion-weighted imaging (DWI) sequence that acquires and averages images from multiple diffusion directions, similar to the method used in high-field MRI scanners. This capability produces cleaner, more consistent images that are especially valuable for stroke diagnosis, enabling better detection of small strokes and enhancing the value of the Swoop® system in acute neurological care. The software is part of the next-generation Swoop® system and is also available as a standalone software upgrade, so existing users benefit from the same powerful imaging platform.
These approvals cover markets across the European Economic Area and the United Kingdom, representing a significant global healthcare market opportunity. The Swoop® system is currently commercialized in these markets through a strong network of distributors across over a dozen countries.
“We are proud to bring our most innovative technology to clinicians and patients in Europe and the UK and are thrilled to have achieved these approvals ahead of our internal expectations,” said Maria Sainz, President and CEO of Hyperfine. “This milestone is a testament to the exceptional execution of our product and regulatory teams and meaningfully advances a key pillar of Hyperfine’s 2026 international growth strategy. We believe that the next-generation Swoop® system will accelerate international adoption of our technology and strengthen our position as the global leader in AI-powered portable brain imaging.”
Hyperfine plans to initiate commercialization of the next-generation Swoop® system and the latest Optive AI™ software in Europe and the UK early in the third quarter of 2026.
For more information about the Swoop® system, please visit HyperfineMRI.com.
About the Swoop® Portable MRI Systems
The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
About Hyperfine, Inc.
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit HyperfineMRI.com.
Hyperfine, the Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy, including its entrance into new markets. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the inability to maintain the listing of the Company’s Class A common stock on the Nasdaq Stock Market; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to progress on product advancements and improvements; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; anticipated National Institutes of Health funding pressures; the effect of U.S. export controls and tariffs; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260409030745/en/
Media Contact
Devin Zell
Hyperfine
dzell@hyperfine.io
Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com
Original: Hyperfine Receives CE and UKCA Marks for Next-Generation Swoop® System and Latest Advancement in Optive AI™ Software
US Market News
2月前
How Decentralized AI is Unlocking Value in Cardiac DiagnosticsMarch 27, 2026 9:30 AM
PR Newswire (US)
ISSUED ON BEHALF OF VENTRIPOINT DIAGNOSTICS LTD.VANCOUVER,BC, March 27, 2026 /PRNewswire/ -- USANewsGroup.com News Commentary – Heart disease is a quiet crisis that is draining healthcare resources worldwide, currently costing the European Union over €282 billion annually while tragically claiming 1.7 million lives a year[1]. This immense structural pressure is acting as a catalyst for smart money, with institutional capital rapidly accumulating positions in scalable, AI-enabled diagnostic platforms. In fact, peer-reviewed data now confirms that AI-driven healthcare startups command the largest share of venture funding in the entire biopharmaceutical sector[2]. At the center of this pivotal transition are five companies building the infrastructure for the next cycle of predictive cardiology: VentriPoint Diagnostics (TSXV: VPT) (OTCPK: VPTDF), HeartBeam (NASDAQ: BEAT), Heartflow (NASDAQ: HTFL), Hyperfine (NASDAQ: HYPR), and GE Healthcare Technologies (NASDAQ: GEHC).
This momentum is not just financial; it is heavily backed by the highest levels of medical regulation. The FDA's authorized registry of AI medical devices has just surpassed 1,200 approved products, with cardiovascular applications emerging as the second largest category overall[3]. This robust regulatory tailwind perfectly aligns with a severe clinical urgency. According to the landmark JACC Cardiovascular Statistics 2026 report, nearly half of all American adults now meet the criteria for hypertension. Because broader treatment and control rates have remained stagnant for over a decade, the market is making it clear that scalable, decentralized AI imaging solutions are the ultimate value drivers for this next healthcare cycle[4].VentriPoint Diagnostics (TSXV: VPT) (OTCPK: VPTDF) is expanding into remote healthcare after announcing a partnership with First Light Health, an Indigenous-owned medical services company based in Vancouver, to deliver AI-powered cardiac diagnostics to Indigenous and remote communities across Canada.Together, the two companies are developing a hub-and-spoke care model built around VentriPoint's VMS+™ system. Local providers in remote areas will capture ultrasound scans on-site and be supported by specialists at a central hub who are able to digitally access images and assist with interpretation. That gives patients in British Columbia, Yukon, Alberta, Manitoba, and New Brunswick access to advanced cardiac imaging without travelling hundreds of kilometres, at lower cost and with faster turnaround than traditional referral pathways. Following validation of the model, Ventripoint plans to scale it beyond Canada into underserved communities globally.VentriPoint's VMS+™ system converts standard 2D echocardiograms into detailed 3D volumetric images. The company says its accuracy is comparable to cardiac MRI, but at a fraction of the cost and without the infrastructure those machines require. For communities where heart disease rates are high and specialist access is limited, the difference between early diagnosis and late diagnosis can be the difference between treatment and tragedy."Cardiovascular disease doesn't respect geography, but too often, access to cardiac care does," said Hugh MacNaught, CEO of VentriPoint Diagnostics. "Our work with First Light Health and other First Nations partners such as the Nisga_'a Valley Health Authority demonstrates the need for a made-in-Canada innovation that can close that gap. We see the potential for this solution to be widely deployed, from the Arctic to the Amazon. This is what scalable, equitable heart care looks like."First Light Health brings cultural safety expertise and established relationships within First Nations communities, which matters when deploying health technology in populations that have historically been underserved by the broader system.The partnership builds on recent commercial traction. VentriPoint signed a commercial agreement with LG Consulting Solutions to support VMS+™ deployment across Northern California, targeting cardiac centres in the Sacramento and San Francisco regions. Before that, the company had already partnered with the Nisga_'a Valley Health Authority to pilot a similar model in northern BC.VentriPoint is a Toronto-based medtech company with regulatory approvals in the United States, Canada, and Europe. Its VMS+™ platform works with ultrasound equipment from any vendor and is built on over a decade of Knowledge Based Reconstruction technology development. The goal is simple: put MRI-grade cardiac diagnostics within reach of any clinic or community that needs them.CONTINUED… Read this and more news for VentriPoint Diagnostics at: https://usanewsgroup.com/2025/11/21/the-mri-grade-disruption-hiding-in-plain-sight-why-the-smart-money-is-watching-ventripointIn other industry developments and happenings in the market include:HeartBeam (NASDAQ: BEAT) recently announced a strategic AI collaboration with the Icahn School of Medicine at Mount Sinai to jointly develop and validate next-generation AI-ECG algorithms using HeartBeam's patented 3D ECG platform, which is the only system capable of collecting synthesized 12-lead ECG data from patients in the home setting continuously over time. The partnership combines HeartBeam's longitudinal real-world ECG datasets with Mount Sinai's clinically annotated 12-lead data to accelerate training of personalized cardiac AI models for applications including heart attack risk assessment."We believe expanding access to 12-lead ECG data assessment beyond the clinic is one of the biggest opportunities," said Robert Eno, CEO of HeartBeam. "By pairing our ability to gather high-fidelity real-world ECG data with Mount Sinai's extensive clinical data resources and AI expertise, we are creating a differentiated cardiac intelligence engine that can scale beyond traditional care settings and broaden the reach of predictive cardiology, ultimately expanding our clinical and commercial opportunity."HeartBeam's 3D ECG technology received FDA clearance for arrhythmia assessment in December 2024 and for 12-lead ECG synthesis in December 2025, providing a regulatory foundation for the expanded AI applications this collaboration targets. The resulting data engine is expected to support entry into new clinical indications and reimbursement pathways over time.Heartflow (NASDAQ: HTFL) announced new clinical evidence and a landmark registry launch at the American College of Cardiology Annual Scientific Session, with data from a 15,000-patient registry showing that high plaque volume independently predicts a fourfold increase in major adverse cardiovascular events regardless of conventional risk factors or stenosis severity. Simultaneously, Heartflow enrolled the first patient in the NAVIGATE-PCI Registry, a 5,000-patient study assessing the real-world impact of AI-guided CT-based pre-procedural planning on clinical strategy and physician confidence in the catheterization lab."These milestones reflect tremendous progress toward Heartflow's goal of transforming coronary artery disease from the world's leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life," said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. "The Heartflow Plaque Analysis data presented at ACC and the launch of the NAVIGATE-PCI Registry represent important steps in building the rigorous real-world evidence needed to support AI-driven decision-making across the full continuum of cardiovascular care."Heartflow has now been adopted by more than 1,400 institutions globally and its technology is backed by over 600 peer-reviewed publications covering more than 500,000 patients. Commercial availability of the Heartflow PCI Navigator is expected in Q2 2026, positioning the company to expand its platform from risk stratification into guided intervention planning.Hyperfine (NASDAQ: HYPR) published breakthrough stroke detection data for its Swoop portable MRI system in the journal Stroke: Vascular and Interventional Neurology, with the next-generation scanner's advanced multi-directional DWI sequence achieving 100% sensitivity and 100% specificity for clinically relevant lesions greater than 1.0 mL, detecting strokes as small as 2.8 mm while cutting scan time by approximately 30%. The prospective multi-center study across Massachusetts General Hospital, Buffalo General Medical Center, and Yale New Haven Hospital represents the largest dataset to date evaluating portable MRI for stroke detection."Stroke detection represents a critical driver of the Swoop system's expansion into emergency departments," said Maria Sainz, President and CEO of Hyperfine. "The results from our next-generation Swoop system, combined with our new, advanced multi-direction DWI sequence that was recently cleared by the FDA, are truly remarkable. This data gives us even greater confidence that the Swoop system can reliably detect clinically relevant strokes, streamline workflows, and further strengthen the value of integrating portable MRI into stroke diagnosis and care."With FDA clearance for its multi-directional DWI sequence now secured and real-world performance validated across multiple clinical sites, Hyperfine is positioned to accelerate emergency department adoption of the Swoop platform. The system's portability and speed open new access pathways for stroke diagnosis in settings where conventional MRI is not clinically practical.GE Healthcare Technologies (NASDAQ: GEHC) announced its lead industrial role in COMPASS, a five-year, €50.5 million consortium backed by the European Union's Innovative Health Initiative and more than sixty partners focused on advancing early detection of cardiovascular toxicity in cancer patients across Europe. The program will leverage AI, advanced imaging, novel biomarkers, and integrated care pathways to address cardiotoxicity, which accounts for up to 10% of mortality in cancer survivors."This initiative is well positioned to enable patient-centered cancer care that takes cardiotoxicity risk into account, supports the early detection of cardiotoxic side-effects, and promotes long-term heart health for oncology patients," said Eigil Samset, General Manager, Cardiology Solutions at GE Healthcare and COMPASS Industry Lead. "By developing an AI-powered, integrated care pathway that connects oncologists and cardiologists in clinical practice, this collaboration has the potential to further improve cancer survival by tackling cardiovascular-related morbidity."The COMPASS grant agreement was signed on March 25, 2026 and runs for five years, with GE Healthcare positioned to advance its AI and imaging capabilities within the largest public-private healthcare partnership under the IHI framework. The initiative supports GE Healthcare's broader cardiology solutions strategy as part of its $20.6 billion global healthcare platform.Further Reading: https://usanewsgroup.com/2025/11/21/the-mri-grade-disruption-hiding-in-plain-sight-why-the-smart-money-is-watching-ventripointCONTACT:USA NEWS GROUPinfo @acblanke1DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. (MIQ). This article is being distributed for Baystreet.ca media Corp, who has been paid a fee for an advertising campaign. MIQ has not been paid a fee for Ventripoint Diagnostics Ltd. advertising or digital media, but the owner/operators of MIQ also co-owns Baystreet.ca Media Corp. (BAY) There may also be 3rd parties who may have shares of Ventripoint Diagnostics Ltd. and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ/BAY own shares of Ventripoint Diagnostics Ltd and reserve the right to buy and sell, and will buy and sell shares of Ventripoint Diagnostics Ltd. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ on behalf of BAY has been approved by Ventripoint Diagnostics Ltd.; this is a paid advertisement, we currently own shares of Ventripoint Diagnostics Ltd. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment.SOURCES:https://www.oecd.org/en/publications/the-state-of-cardiovascular-health-in-the-european-union_ea7a15f4-en/full-report/the-burden-of-cardiovascular-disease_e28210c3.html
https://www.jmir.org/2026/1/e84968
https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices
https://www.jacc.org/doi/10.1016/j.jacc.2025.12.027Logo - https://mma.prnewswire.com/media/2838876/5886720/USA_News_Group_Logo.jpg
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Original: How Decentralized AI is Unlocking Value in Cardiac Diagnostics
US Market News
3月前
Hyperfine, Inc. Reports Fourth Quarter and Full Year 2025 Financial ResultsMarch 18, 2026 4:05 PM
Business Wire
Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced fourth quarter and full year 2025 financial results and provided a business update.
“The launch of our second-generation Swoop® scanner, our Optive AI™ software, and the addition of a new market in the neurology office setting in mid-2025 marks a new era in the adoption of portable brain MRI and the future of our company. We hold a highly proprietary and differentiated technology leadership position in the ability to produce diagnostic quality images with an ultra-low-field magnet,” said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc. “As we move through 2026, we expect to continue to see growth catalysts accelerate the adoption of the Swoop® system across multiple sites of care in the hospital, neurology office and international markets.”
Recent Achievements and Business Highlights
Obtained FDA clearance of the first Optive AI™ software update with advanced diffusion imaging capability, focused on enhancing stroke detection.
Enrolled first patient in Contrast PMR, a study designed to support a future FDA 510(k) submission to expand the Swoop® system’s intended use to include gadolinium-based contrast agents.
Presented NEURO-PMR results at the 2026 American Society of Neuroimaging showing high diagnostic value and superior patient experience in neurology clinics.
Published paper in Stroke: Vascular and Interventional Neurology (SVIN) demonstrating the Swoop® system’s enhanced stroke detection capabilities.
Published paper in Clinical Neuroimaging demonstrating the significant health economic benefit of using the Swoop® system.
Received regulatory approval in India from the Central Drugs Standard Control Organization for the first-generation Swoop® system.
Awarded $3.7 million grant from the Gates Foundation to advance global brain health.
Raised over $20 million in gross proceeds through an equity public offering in October 2025.
Secured a $40 million senior secured term loan facility in March 2026, with initial funding of $15 million and an additional $25 million available upon achievement of certain commercial milestones.
Bolstered balance sheet with expected cash runway into 2028, including recent equity financing and the initial debt tranche, providing capital for commercial growth.
Fourth Quarter 2025 Financial Results
Revenues for the fourth quarter of 2025 were $5.29 million, increasing 128% compared to $2.32 million in the fourth quarter of 2024.
Sold net 16 commercial Swoop® systems in the fourth quarter of 2025, compared to nine in the fourth quarter of 2024.
Gross profit for the fourth quarter of 2025 was $2.69 million, compared to $0.83 million in the fourth quarter of 2024, representing 51% gross margin in the fourth quarter of 2025, compared to 36% gross margin in the fourth quarter of 2024.
Research and development expenses for the fourth quarter of 2025 were $3.82 million, compared to $5.11 million in the fourth quarter of 2024.
Sales, marketing, general, and administrative expenses for the fourth quarter of 2025 were $6.54 million, compared to $6.49 million in the fourth quarter of 2024.
Net loss for the fourth quarter of 2025 was $5.91 million, equating to a net loss of $0.06 per share, as compared to a net loss of $10.39 million, or a net loss of $0.14 per share, for the fourth quarter of 2024. The fourth quarter of 2025 net loss includes a gain from the change in fair value of warrant liabilities of $1.46 million.
Full Year 2025 Financial Results
Revenues for the full year 2025 were $13.56 million, increasing 5.2% compared to $12.89 million in 2024.
Sold net 38 commercial Swoop® systems in 2025, compared to 48 in 2024.
Gross profit for the full year 2025 was $6.75 million, compared to $5.89 million in 2024, representing 50% gross margin in 2025, compared to 46% gross margin in 2024.
Research and development expenses for the full year 2025 were $17.45 million, compared to $22.50 million in 2024.
Sales, marketing, general, and administrative expenses for the full year 2025 were $26.39 million, compared to $26.62 million in 2024.
Net loss for the full year 2025 was $35.57 million, equating to a net loss of $0.43 per share, as compared to a net loss of $40.72 million, or a net loss of $0.56 per share, for 2024. The full year 2025 net loss includes a gain from the change in fair value of warrant liabilities of $0.83 million.
Cash and cash equivalents totaled $35.09 million as of December 31, 2025.
2026 Financial Guidance
Management expects revenue for the full year 2026 to be approximately $20 to $22 million, representing 55% growth at the midpoint as compared to full year 2025.
Management expects cash burn1 for the full year 2026 to be approximately $26 to $28 million, representing a 10% decline at the midpoint as compared to full year 2025.
1Cash burn is calculated as change in cash and cash equivalents less net financing proceeds.
Conference Call
Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Wednesday, March 18, 2026 to discuss its fourth quarter and full year 2025 financial results and provide a business update. Those interested in listening should register online by visiting https://investors.hyperfine.io/ and clicking on News & Events. Participants are encouraged to register more than 15 minutes before the start of the call. A live and archived audio webcast will be available through the Investors page of Hyperfine, Inc.’s corporate website at https://investors.hyperfine.io/.
About Hyperfine, Inc. and the Swoop® Portable MR Imaging® Systems
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first U.S. Food and Drug Administration (FDA)-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit hyperfine.io.
The Swoop® Portable MR Imaging® systems are FDA cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The Swoop® system also has CE Mark in the European Union and UKCA Mark in the United Kingdom. The Swoop® system is commercially available in a select number of international markets.
Hyperfine, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations about the Company’s financial and operating results, including, the Company’s expected revenue and cash burn for the full year 2026, the Company's cash runway, the Company’s goals and commercial plans, including the Company’s commercial rollout of the Company’s Optive AI™ software and next generation Swoop® system, the acceleration of the adoption of the Swoop® system across multiple sites of care in the hospital, neurology office and international markets, the benefits of the Company’s products and services, progress on improvements and advancements in the Company’s products and services, and the Company’s future performance, including its financial performance, and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the Company’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the ability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the ability of the Company to identify, in-license or acquire additional technology; the ability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; the ability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; the Company’s ability to successfully complete and generate positive data from the PRIME study, ACTION PMR study, Contrast PMR study, CARE PMR study and NEURO PMR study; the Company’s ability to generate clinical evidence of the benefits of the Company’s products and services and to progress on product advancements and improvements; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
HYPERFINE, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
(Unaudited)
December 31,
2025
2024
ASSETS
CURRENT ASSETS:
Cash and cash equivalents
$
35,085
$
37,645
Restricted cash
957
28
Accounts receivable, less allowance of $1,372 and $651 in 2025 and 2024, respectively
5,254
5,956
Unbilled receivables
1,268
2,349
Inventory
7,090
5,832
Prepaid expenses and other current assets
1,255
1,900
Total current assets
$
50,909
$
53,710
Property and equipment, net
2,549
3,122
Other long term assets
1,804
2,069
Total assets
$
55,262
$
58,901
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable
$
4,051
$
1,607
Deferred grant funding
957
28
Deferred revenue
1,544
1,460
Due to related parties
50
61
Accrued expenses and other current liabilities
5,130
5,573
Total current liabilities
$
11,732
$
8,729
Warrant liabilities
1,730
—
Long term deferred revenue
729
1,054
Other noncurrent liabilities
66
78
Total liabilities
$
14,257
$
9,861
STOCKHOLDERS' EQUITY:
Class A Common stock, $.0001 par value; 600,000,000 shares authorized; 82,166,458 and 58,076,261 shares issued and outstanding at December 31, 2025 and 2024, respectively
8
5
Class B Common stock, $.0001 par value; 27,000,000 shares authorized; 15,055,288 shares issued and outstanding at December 31, 2025 and 2024
2
2
Additional paid-in capital
371,011
343,475
Accumulated deficit
(330,016
)
(294,442
)
Total stockholders' equity
$
41,005
$
49,040
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
$
55,262
$
58,901
HYPERFINE, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS
(in thousands, except share and per share amounts)
(Unaudited)
Three Months Ended
December 31,
Twelve Months Ended
December 31,
2025
2024
2025
2024
Sales
Device
$
4,857
$
1,743
$
11,398
$
10,450
Service
436
578
2,165
2,440
Total sales
$
5,293
$
2,321
$
13,563
$
12,890
Cost of sales
Device
$
2,345
$
1,107
$
5,755
$
5,387
Service
254
388
1,055
1,612
Total cost of sales
$
2,599
$
1,495
$
6,810
$
6,999
Gross profit
2,694
826
6,753
5,891
Operating Expenses:
Research and development
$
3,825
$
5,105
$
17,451
$
22,499
General and administrative
4,034
4,133
16,253
17,494
Sales and marketing
2,503
2,353
10,134
9,122
Total operating expenses
$
10,362
$
11,591
$
43,838
$
49,115
Loss from operations
$
(7,668
)
$
(10,765
)
$
(37,085
)
$
(43,224
)
Interest income
$
280
$
436
$
1,023
$
2,492
Change in fair value of warrant liabilities
1,464
—
825
—
Other income (expense), net
12
(61
)
(337
)
12
Loss before provision for income taxes
$
(5,912
)
$
(10,390
)
$
(35,574
)
$
(40,720
)
Provision for income taxes
—
—
—
—
Net loss and comprehensive loss
$
(5,912
)
$
(10,390
)
$
(35,574
)
$
(40,720
)
Net loss per common share attributable to common stockholders, basic and diluted
$
(0.06
)
$
(0.14
)
$
(0.43
)
$
(0.56
)
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted
94,204,138
72,990,908
81,795,105
72,413,541
HYPERFINE, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENT OF CASH FLOWS
(in thousands)
(Unaudited)
Year Ended December 31,
2025
2024
Cash flows from operating activities:
Net loss
$
(35,574
)
$
(40,720
)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
1,090
1,009
Stock-based compensation expense
2,801
4,362
Write-off of equipment
121
215
Change in fair value of warrant liabilities
(825
)
—
Other
27
(11
)
Changes in assets and liabilities
Accounts receivable
702
(2,767
)
Unbilled receivables
1,081
(1,407
)
Inventory
(1,475
)
562
Prepaid expenses and other current assets
436
(222
)
Prepaid inventory
—
693
Other long term assets
240
325
Accounts payable
2,427
382
Deferred grant funding
929
(593
)
Deferred revenue
(241
)
93
Due to related parties
(11
)
—
Accrued expenses and other current liabilities
332
(683
)
Operating lease liabilities, net
(8
)
(5
)
Net cash used in operating activities
$
(27,948
)
$
(38,767
)
Cash flows from investing activities:
Purchases of property and equipment
(1,185
)
(383
)
Net cash used in investing activities
$
(1,185
)
$
(383
)
Cash flows from financing activities:
Proceeds from exercise of stock options
$
156
$
171
Proceeds from issuance of Class A common stock under “at-the-market” offering program, net
3,383
848
Proceeds from issuance of Class A common stock with warrants under February 2025 Offering, net
5,183
—
Proceeds from issuance of Class A common stock under October 2025 Offering, net
18,443
—
Proceeds from issuance of Class A common stock in connection with warrant exercises
337
—
Net cash provided by financing activities
$
27,502
$
1,019
Net decrease in cash and cash equivalents and restricted cash
(1,631
)
(38,131
)
Cash, cash equivalents and restricted cash, beginning of year
37,673
75,804
Cash, cash equivalents and restricted cash, end of year
$
36,042
$
37,673
Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets
Cash and cash equivalents
$
35,085
$
37,645
Restricted cash
957
28
Total cash, cash equivalents and restricted cash
$
36,042
$
37,673
Supplemental disclosure of noncash information:
Noncash acquisition of property and equipment
$
217
$
765
Unpaid purchase of property and equipment
$
31
$
—
Initial measurement of warrant liabilities
$
2,858
$
—
View source version on businesswire.com: https://www.businesswire.com/news/home/20260318436530/en/
Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com
Original: Hyperfine, Inc. Reports Fourth Quarter and Full Year 2025 Financial Results
US Market News
4月前
Hyperfine Announces Publication of Breakthrough Clinical Data Demonstrating the Swoop® System’s Enhanced Stroke Detection CapabilitiesJanuary 27, 2026 1:15 PM
Business Wire
The largest dataset to date on stroke detection with the Swoop® system demonstrates the ability to identify small strokes rapidly and reliably, reinforcing its clinical value for acute care and emergency settings.
Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable MRI system for the brain—the Swoop® system—today announced results from the largest data set to date evaluating stroke detection with the Swoop® system. This data provides strong evidence supporting the use of AI-powered portable MRI for stroke detection in multiple clinical settings, including the emergency department.
The prospective multi-center observational study, published in the November issue of Stroke: Vascular and Interventional Neurology (SVIN), evaluates 95 patients, combining data from the ACTION PMR study at Massachusetts General Hospital and Buffalo General Medical Center, with data from Yale New Haven Hospital. The study evaluated the sensitivity and specificity of ischemic lesion detection, comparing both the original and next-generation Swoop® system scanners, along with a comparison of two types of DWI sequences, a sequence that is critical for stroke detection.
The advanced multi-directional DWI sequence on the next-generation Swoop® system achieved dramatic improvements in diagnostic performance over the original scanner:
Enhanced Detection of Small Lesions: Successfully identified lesions as small as 2.8 mm (0.15 mL), enabling detection of very small strokes
Perfect Accuracy for Clinically Relevant Lesions: Achieved 100% sensitivity and 100% specificity for lesions greater than 1.0 mL.
Improved Efficiency: Reduced scan time by approximately 30%, making stroke imaging feasible in time-critical emergency settings
Superior Image Quality: Demonstrated improved image uniformity across the brain, enhancing diagnostic confidence
“We previously showed that using DWI in combination with FLAIR on the portable MRI system can be used as a 'tissue clock' for stroke detection, similar to conventional MRI. With this study, we took the next step and evaluated the capability of ultra-low-field MRI with advanced, multi-directional DWI sequences to detect very small ischemic lesions,” said Taylor Kimberly, MD, PhD, Chief of the Neurocritical Care Division at Mass General Brigham. “The results show that the next-generation portable MRI system with a multi-directional DWI sequence enables detection of very small strokes in a clinically feasible timeframe. The portable MRI system’s ability to detect clinically relevant strokes opens new possibilities for transforming stroke diagnosis and management—bringing timely evaluation to more patients and care settings than ever before.”
"Stroke detection represents a critical driver of the Swoop® system's expansion into emergency departments,” commented Maria Sainz, President and CEO of Hyperfine. “The results from our next-generation Swoop® system, combined with our new, advanced multi-direction DWI sequence that was recently cleared by the FDA, are truly remarkable. This data gives us even greater confidence that the Swoop® system can reliably detect clinically relevant strokes, streamline workflows, and further strengthen the value of integrating portable MRI into stroke diagnosis and care.”
Hyperfine provided portable MRI systems as part of sponsored research agreements. The company was not involved in the design or analysis of this investigator-initiated study, nor in the publication decision.
For more information about the Swoop® system, please visit HyperfineMRI.com.
About the Swoop® Portable MRI Systems
The Swoop® Portable MR Imaging® Systems are U.S. Food and Drug Administration (FDA) cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis.
About Hyperfine, Inc.
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit HyperfineMRI.com.
The Hyperfine logo, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. The Swoop logo, Optive AI logo, and Optive AI are trademarks of Hyperfine, Inc.
Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, the Company’s goals and commercial plans, the benefits of the Company’s products and services, and the Company’s future performance and its ability to implement its strategy, including its entrance into new markets. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the inability to maintain the listing of the Company’s Class A common stock on the Nasdaq Stock Market; the Company’s inability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the inability of the Company to raise financing in the future; the inability of the Company to progress on product advancements and improvements; the inability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the inability of the Company to identify, in-license or acquire additional technology; the inability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; the inability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; anticipated National Institutes of Health funding pressures; the effect of U.S. export controls and tariffs; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements, which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260127416816/en/
Media Contact
Devin Zell
Hyperfine
dzell@hyperfine.io
Investor Contact
Webb Campbell
Gilmartin Group LLC
webb@gilmartinir.com
Original: Hyperfine Announces Publication of Breakthrough Clinical Data Demonstrating the Swoop® System’s Enhanced Stroke Detection Capabilities