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