Masimo (NASDAQ: MASI) today announced that the Masimo W1™
medical watch has received FDA 510(k) clearance for
over-the-counter (OTC) and prescription use (Rx). Masimo W1 is the
first FDA-cleared watch to provide continuous real-time oxygen
saturation (SpO2) and pulse rate (PR) for OTC and Rx use. The FDA
clearance expands the indications for the Masimo W1 in the U.S. as
a medical device for use by adults in hospitals, clinics, long-term
care facilities, and in the home. Developed to be comfortable and
lifestyle-friendly, the Masimo W1 medical watch empowers users with
untethered continuous pulse oximetry as they move about their lives
– no matter where they are.
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Masimo W1™ (Photo: Business Wire)
The clinical power of the Masimo W1 comes from its integrated
Masimo MW-1 sensor, hardware, and software module, which
incorporates over 30 years of Signal Extraction Technology® pulse
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 heart rate (HR) from an ECG. The
continuous pulse oximetry data, under the care of a physician, can
give greater visibility of changes in oxygen saturation to help
patients better manage their oxygen levels daily. Managing oxygen
levels can be prescribed for recovery after surgery, managing
chronic breathing conditions (e.g., COPD), and for patients with
congenital heart failure (CHF).
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. To help individuals identify low oxygen
saturation, high pulse rate, or low pulse rate, the SpO2 and PR
values are displayed in red when they fall outside of their normal
ranges.
Joe Kiani, Founder and CEO of Masimo, said, “Clinicians at
numerous prestigious institutions in Europe and the Middle East are
already using Masimo W1 in a variety of innovative ways. For
example, Cambridge University Hospitals in England is using it to
expand their Virtual Health program to support more confident
patient discharge. The Department of Anesthesiology at CHUV in
Lausanne, Switzerland is using Masimo W1 on preoperative patients,
to help anesthesiologists better understand the physiology and
areas to improve for each patient they care for in the hospital,
prior to surgery. We are excited about the hospital-to-home
innovations the Masimo W1 can bring to the U.S, with this FDA
clearance, and the empowerment of patients at home.”
The Masimo W1 and the integrated Masimo MW-1 module are also
intended for the spot-checking of functional oxygen saturation of
arterial hemoglobin (SpO2) and pulse rate (PR). The Masimo W1 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
newborns3 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 9 of the top 10 hospitals as ranked
in the 2022-23 U.S. News and World Report Best Hospitals Honor
Roll.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®. 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
the Masimo W1™ watch. 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.
-
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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 MW-1. 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 MW-1, 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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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