Masimo announced it received FDA clearance of MightySat Medical, making it the first and only FDA-cleared medical fingertip pulse oximeter available over-the-counter direct to consumers without a prescription.

About MightySat Medical

MightySat Medical is a direct-to-consumer option for a medical device with hospital-grade pulse oximetry technology. The device is powered by Masimo SET, which is the same technology used by hospitals and clinics and is shown to have no clinically significant difference in accuracy or bias between light- and dark-skinned individuals.

According to the company, MightySat Medical is intended for the spot-checking of functional oxygen saturation of arterial hemoglobin and pulse rate. It is indicated for use with individuals 18 years and older who are well or poorly perfused under no motion conditions.

Pulse oximeters sold at drug stores, online and direct-to-consumer are not FDA cleared. In 2021, the FDA issued a safety communication to inform patients and health care providers that although pulse oximetry is useful for estimating blood oxygen levels, pulse oximeters have limitations and a risk of inaccuracy under certain circumstances that should be considered.

The MightySat Medical pulse oximeter is available for sale online and will soon be available for purchase at retail stores in the U.S.

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