Masimo Announces the First FDA-cleared “Over-the-Counter” Fingertip Pulse Oximeter

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.

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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

1. 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.
2. Estimate: Masimo data on file.
3. 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.
4. https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication
5. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
6. 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.
7. 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.
8. 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.
9. 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.
10. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
11. 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.
12. 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.

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