Secure Bluetooth® Connectivity Allows
Continuous, Accurate Wrist-based Measurements to be Seamlessly
Relayed to Caregivers via the Masimo Secure Health Data Cloud
Masimo (NASDAQ: MASI) today announced that the Masimo W1®
medical watch has received FDA 510(k) clearance for connectivity,
allowing it to be integrated with the Masimo SafetyNet®
comprehensive telemonitoring solution. Masimo W1 Medical received
FDA clearance last year as the first medical watch to provide
continuous oxygen saturation (SpO2) and pulse rate (PR) for
over-the-counter and prescription use at home and in hospitals. The
combination of Masimo W1 Medical and Masimo SafetyNet allows
accurate and reliable patient data, collected conveniently and
comfortably via the wrist, to be made available on the Masimo
SafetyNet smartphone app and reviewed by remote caregivers,
including by hospital clinicians on the web-based Masimo SafetyNet
clinician portal – anywhere and at any time.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240812430878/en/
Masimo W1® with Masimo SafetyNet® (Photo:
Business Wire)
Joe Kiani, Founder and CEO of Masimo, said, “This is an
important milestone for better health outcomes. For the first time
caregivers can get customized notifications, based on data from an
unobtrusive pulse oximeter worn on the wrist of a patient or loved
one, in situations where it’s logistically difficult to provide
care in person. Masimo W1 Medical with Masimo SafetyNet opens up a
world of possibilities for caregivers looking to improve quality of
care and ultimately improve outcomes for those they care for.”
Mr. Kiani continued, “We’ve been excited to see how institutions
in Europe and the Middle East are already integrating Masimo W1
with Masimo SafetyNet into their practices in a variety of
innovative ways, such as programs that support more confident
patient discharge, help anesthesiologists better understand each
patient’s unique physiology prior to surgery, and drive toward more
predictive, rather than reactive, models of care. And now, with
this FDA clearance, we can not only bring these capabilities to the
U.S., but we can allow regular people to take better care of each
other.”
The clinical power of Masimo W1 Medical comes from its
integrated Masimo MW-1 sensor, hardware, and software module, which
incorporates over 30 years of Signal Extraction Technology® pulse
oximetry and rainbow® Pulse CO-Oximetry knowledge into a single
wearable module. It has an integrated optical sensor and
electrocardiogram (ECG) electrode pads that can be used to detect
physiological signals. The Masimo MW-1 module also processes these
signals using Masimo’s proprietary signal processing algorithms to
output high-resolution SpO2, PR, perfusion index (Pi), and HR from
an ECG.
The continuous data from the Masimo MW-1 module is displayed in
real time on the Masimo W1 watch touchscreen in an
easy-to-interpret format. With the addition of Bluetooth
connectivity, patients can now also take full advantage of the
powerful Masimo SafetyNet app, using their phone to input
additional symptoms into CarePrograms designed by their clinicians,
view their live data and trends, conduct virtual visits with
clinicians, and view educational resources.
In turn, clinicians back at the hospital or doctor’s office can
examine data and trends and receive customized notifications within
the Masimo SafetyNet clinician portal – enabling care providers to
manage their patients beyond the boundaries of the hospital. With
Masimo SafetyNet, clinicians gain valuable insight into how their
patients’ physiological data changes as they go about their day,
helping them better understand their patients so that they can
identify and prioritize patients who need follow up. They can more
easily track patient progress, tailor remote care programs to match
each patient’s needs, and streamline their workflows with
high-fidelity reports, rich analytics, and the integration of
reliable medical data into electronic medical records (EMRs).
In addition to making patient data available to hospital
clinicians via the clinician portal, patients can configure Masimo
SafetyNet so that their data can be shared with other types of
caregivers, such as a family member taking care of their elderly
parents or a loved one. Remote caregivers can also receive
customized updates – helping better assess when to check in with
their loved one.
Making the secure transmission and storage of patient medical
data possible for Masimo SafetyNet is the Masimo SafetyNet cloud:
fast, scalable, and reliably available health cloud storage
tailored to meet hospitals’ strict standards. The Masimo SafetyNet
cloud not only provides the highest level of end-to-end encryption
to ensure that data privacy and security are maintained, but gives
clinicians access to trended patient data and waveforms wherever
they are – supporting more informed clinical insight and analysis.
In addition, the comprehensive data set stored in the cloud can be
used to generate robust, highly detailed reports, making Masimo
SafetyNet a true population health management platform.
Masimo SafetyNet – which also connects to other wearables, like
Masimo Radius PPG® for tetherless fingertip pulse oximetry and
Radius Tº® for continuous wireless thermometry, as well as a
variety of spot-check devices – is now an even more robust,
powerful, and comprehensive telemonitoring solution.
The Masimo W1 medical watch and the integrated Masimo MW-1
module are indicated for adults in hospitals, clinics, long-term
care facilities, and homes.
@Masimo | #Masimo
About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company
that develops and produces a wide array of industry-leading
monitoring technologies, including innovative measurements,
sensors, patient monitors, and automation and connectivity
solutions. In addition, Masimo Consumer Audio is home to eight
legendary audio brands, including Bowers & Wilkins, Denon,
Marantz, and Polk Audio. Our mission is to improve life, improve
patient outcomes, and reduce the cost of care. Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry,
introduced in 1995, has been shown in over 100 independent and
objective studies to outperform other pulse oximetry technologies.1
Masimo SET® has also been shown to help clinicians reduce severe
retinopathy of prematurity in neonates,2 improve CCHD screening in
newborns,3 and, when used for continuous monitoring with Masimo
Patient SafetyNet™ in post-surgical wards, reduce rapid response
team activations, ICU transfers, and costs.4-7 Masimo SET® is
estimated to be used on more than 200 million patients in leading
hospitals and other healthcare settings around the world,8 and is
the primary pulse oximetry at all 10 top U.S. hospitals as ranked
in the 2024 Newsweek World’s Best Hospitals listing.9 In 2005,
Masimo introduced rainbow® Pulse CO-Oximetry technology, allowing
noninvasive and continuous monitoring of blood constituents that
previously could only be measured invasively, including total
hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin
(SpCO®), methemoglobin (SpMet®), Pleth Variability Index (PVi®),
RPVi™ (rainbow® PVi), and Oxygen Reserve Index (ORi™). In 2013,
Masimo introduced the Root® Patient Monitoring and Connectivity
Platform, built from the ground up to be as flexible and expandable
as possible to facilitate the addition of other Masimo and
third-party monitoring technologies; key Masimo additions include
Next Generation SedLine® Brain Function Monitoring, O3® Regional
Oximetry, and ISA™ Capnography with NomoLine® sampling lines.
Masimo’s family of continuous and spot-check monitoring Pulse
CO-Oximeters® includes devices designed for use in a variety of
clinical and non-clinical scenarios, including tetherless, wearable
technology, such as Radius-7®, Radius PPG®, and Radius VSM™,
portable devices like Rad-67®, fingertip pulse oximeters like
MightySat® Rx, and devices available for use both in the hospital
and at home, such as Rad-97® and the Masimo W1® Medical Watch.
Masimo hospital and home automation and connectivity solutions are
centered around the Masimo Hospital Automation™ platform, and
include Iris® Gateway, iSirona™, Patient SafetyNet, Replica®, Halo
ION®, UniView®, UniView :60™, and Masimo SafetyNet®. Its growing
portfolio of health and wellness solutions includes Radius Tº® and
Masimo W1 Sport. Additional information about Masimo and its
products may be found at www.masimo.com. Published clinical studies
on Masimo products can be found at
www.masimo.com/evidence/featured-studies/feature/.
RPVi has not received FDA 510(k) clearance and is not available
for sale in the United States. The use of the trademark Patient
SafetyNet is under license from University HealthSystem
Consortium.
References
- Published clinical studies on pulse oximetry and the benefits
of Masimo SET® can be found on our website at
http://www.masimo.com. Comparative studies include independent and
objective studies which are comprised of abstracts presented at
scientific meetings and peer-reviewed journal articles.
- Castillo A et al. Prevention of Retinopathy of Prematurity in
Preterm Infants through Changes in Clinical Practice and SpO2
Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
- de-Wahl Granelli A et al. Impact of pulse oximetry screening on
the detection of duct dependent congenital heart disease: a Swedish
prospective screening study in 39,821 newborns. BMJ. 2009;Jan
8;338.
- Taenzer A et al. Impact of pulse oximetry surveillance on
rescue events and intensive care unit transfers: a before-and-after
concurrence study. Anesthesiology. 2010:112(2):282-287.
- Taenzer A et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
- McGrath S et al. Surveillance Monitoring Management for General
Care Units: Strategy, Design, and Implementation. The Joint
Commission Journal on Quality and Patient Safety. 2016
Jul;42(7):293-302.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- Estimate: Masimo data on file.
-
https://www.newsweek.com/rankings/worlds-best-hospitals-2024/united-states
Forward-Looking Statements
This press release includes forward-looking statements as
defined in Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934, in connection with the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, among others, statements
regarding the potential effectiveness of Masimo W1® and Masimo
SafetyNet®. These forward-looking statements are based on current
expectations about future events affecting us and are subject to
risks and uncertainties, all of which are difficult to predict and
many of which are beyond our control and could cause our actual
results to differ materially and adversely from those expressed in
our forward-looking statements as a result of various risk factors,
including, but not limited to: risks related to our assumptions
regarding the repeatability of clinical results; risks related to
our belief that Masimo's unique noninvasive measurement
technologies, including Masimo W1 and Masimo, contribute to
positive clinical outcomes and patient safety; risks related to our
belief that Masimo noninvasive medical breakthroughs provide
cost-effective solutions and unique advantages; risks related to
COVID-19; as well as other factors discussed in the "Risk Factors"
section of our most recent reports filed with the Securities and
Exchange Commission ("SEC"), which may be obtained for free at the
SEC's website at www.sec.gov. Although we believe that the
expectations reflected in our forward-looking statements are
reasonable, we do not know whether our expectations will prove
correct. All forward-looking statements included in this press
release are expressly qualified in their entirety by the foregoing
cautionary statements. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of today's date. We do not undertake any obligation to update,
amend or clarify these statements or the "Risk Factors" contained
in our most recent reports filed with the SEC, whether as a result
of new information, future events or otherwise, except as may be
required under the applicable securities laws.
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version on businesswire.com: https://www.businesswire.com/news/home/20240812430878/en/
Media Contact: Masimo Evan Lamb 949-396-3376
elamb@masimo.com
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