Masimo MightySat® Medical Provides Clinically
Proven Masimo SET® Pulse Oximetry to Consumers for Medical Use
Without a Prescription
Masimo (NASDAQ: MASI) announced today FDA clearance of
MightySat® Medical, making it the first and only FDA-cleared
medical fingertip pulse oximeter available Over-The-Counter (OTC)
direct to consumers without a prescription. All other pulse
oximeters available at drug stores and online and sold direct to
consumers are not FDA cleared and should not be relied upon for
medical use; many of them have been reported to give erroneous
measurements.1 This clearance brings consumers a pulse oximeter
medical device powered by Masimo SET® pulse oximetry—the same
technology relied on by hospitals and clinics around the world to
monitor more than 200 million patients every year2 and shown to
have no clinically significant difference in accuracy or bias
between light- and dark-skinned individuals.3 Starting today, the
MightySat Medical Pulse Oximeter can be purchased at masimo.com,
and it will soon be available for purchase at retail and drug
stores across the country.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20240213849120/en/
Masimo MightySat® Medical (Photo:
Business Wire)
Joe Kiani, Founder and CEO of Masimo, said, “Until now,
consumers and even healthcare providers had no way of knowing what
pulse oximeter they could trust to use at home. On the internet and
even in drug stores, they are inundated with a myriad of products
that are unreliable, with misleading advertisements about their
abilities to provide accurate measurements of oxygen saturation and
pulse rate. This clearance of MightySat Medical for consumers
eliminates the confusion, placing an FDA-cleared, accurate,
reliable, and revolutionary SET® pulse oximeter, with technology
that hospitals have been using for more than 25 years, directly
into their hands. Healthcare providers can also now be confident
when referring their patients to get MightySat Medical knowing that
it has actually been cleared by the FDA as an OTC medical pulse
oximeter.”
In 2021, the FDA issued a safety communication clarifying that
it does not review the accuracy of “health and wellness” pulse
oximeters and highlighting the common limitations of both health
and wellness and some prescription pulse oximeters—such as
difficulty measuring accurately during patient motion, on patients
with poor circulation (low perfusion), and on darker skin
pigmentation.4 The overwhelming majority of consumers say that
device accuracy—measurements they can trust—is their top priority
when choosing a pulse oximeter. MightySat Medical provides a
direct-to-consumer option for a medical device with hospital-grade
pulse oximetry technology, Masimo SET®, whose performance has been
reviewed and cleared by the FDA for medical use. MightySat Medical
provides accurate and reliable oxygen saturation (SpO2) and pulse
rate (PR) measurements on patients of all skin colors and patients
with low perfusion.
Consumers with diagnosed breathing problems or lung diseases
such as asthma, chronic obstructive pulmonary disease (COPD), lung
cancer, flu, pneumonia, or COVID-19 depend on accurate assessment
of their arterial blood oxygen saturation that they can confidently
share with their healthcare providers. Prior to the FDA clearance
of MightySat Medical, consumers were only able to buy unregulated
health and wellness devices without a prescription. Now, MightySat
Medical with Masimo SET® provides an FDA-cleared medical device
with validated accuracy without the need for a prescription. SET®,
available in numerous hospital devices, is the primary pulse
oximetry technology at 9 of the top 10 U.S. hospitals listed in the
U.S. News and World Report Honor Roll.5 In addition, over 100
independent and objective studies have shown that SET® outperforms
other pulse oximetry technologies.6
Peter Pronovost, MD, PhD, Chief Quality and Clinical
Transformation Officer, University Hospitals, Cleveland, commented,
“More and more care is moving to the patient’s home. Patients now
have the ability to monitor their oxygen levels and pulse rate,
which can help them know when they need to seek care. Yet to be
useful, their pulse oximetry data must be accurate and the accuracy
of these devices varies widely. Doctors and nurses rely on Masimo
technology in the hospital.”
Masimo MightySat Medical is intended for the spot-checking of
functional oxygen saturation of arterial hemoglobin (SpO2) and
pulse rate (PR).
MightySat Medical is indicated for use with individuals 18 years
and older who are well or poorly perfused under no motion
conditions.
MightySat Medical is not intended for the diagnosis or screening
of lung disease. Treatment decisions using the device should only
be made under the advice of a healthcare provider.
@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.6
Masimo SET® has also been shown to help clinicians reduce severe
retinopathy of prematurity in neonates,7 improve CCHD screening in
newborns8 and, when used for continuous monitoring with Masimo
Patient SafetyNet™ in post-surgical wards, reduce rapid response
team activations, ICU transfers, and costs.9-12 Masimo SET® is
estimated to be used on more than 200 million patients in leading
hospitals and other healthcare settings around the world,2 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.5 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®, Masimo W1 Sport, and Masimo Stork™. Additional
information about Masimo and its products may be found at
www.masimo.com. Published clinical studies on Masimo products can
be found at
professional.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
- Lipnick M, Feiner J, Au P, Bernstein M, Bickler P. The Accuracy
of 6 Inexpensive Pulse Oximeters Not Cleared by the Food and Drug
Administration: The Possible Global Public Health Implications.
Anesth Anal. Aug 2016. 123(2)338-345. DOI:
10.1213/ANE.0000000000001300.
- Estimate: Masimo data on file.
- Barker SJ, Wilson WC. Racial effects on Masimo pulse oximetry:
a laboratory study. J Clin Monit Comput. 2023 Apr;37(2):567-574.
DOI: 10.1007/s10877-022-00927-w.
-
https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication
-
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
- 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.
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 MightySat® and SET®. 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 MightySat and SET®, 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 that
MightySat may not soon be available for purchase at retail and drug
stores across the country and online; 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240213849120/en/
Media Contact: Masimo Evan Lamb 949-396-3376
elamb@masimo.com
Masimo (NASDAQ:MASI)
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