Masimo announces FDA-cleared ‘over-the-counter’ fingertip pulse oximeter

Masimo announced 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.