FDA clears 1st over-the-counter pulse oximeter for home use

New MightySat Medical can help COPD patients test blood oxygen levels

Lindsey Shapiro PhD avatar

by Lindsey Shapiro PhD |

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The U.S. Food and Drug Administration (FDA) for the first time has cleared a fingertip pulse oximeter for home use as a medical device that consumers — including people with chronic obstructive pulmonary disease (COPD) — can use to check their blood oxygen levels.

The device, MightySat Medical from Masimo, is available from the company for $299.99, and will soon be in retail stores across the U.S., according to a company press release.

Pulse oximeters are electronic devices that, usually clipped to a fingertip, measure a person’s oxygen saturation, or the amount of oxygen being carried by the body’s red blood cells, as well as and individual’s heart rate.

Such over-the-counter versions of these devices — routinely used to monitor people with lung conditions such as COPD — have been widely available at drugstores and online for many years. But until now, none of these devices had undergone an FDA review for accuracy, and none was designed for medical use.

“Until now, consumers and even healthcare providers had no way of knowing what pulse oximeter they could trust to use at home,” said Joe Kiani, founder and CEO of Masimo. The FDA clearance “eliminates the confusion,” Kiani said.

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The lungs are responsible for adding oxygen to the blood. In severe COPD, where the lungs are substantially damaged, patients may have reduced oxygen transport throughout the body.

People with COPD and other chronic lung conditions use pulse oximeters to make sure their blood oxygen levels are sufficient for proper organ function. At-home devices allow patients to self-monitor their oxygen levels, helping to lower the healthcare burden for patients.

“More and more care is moving to the patient’s home,” Peter Pronovost, MD, chief quality and clinical transformation officer of the University Hospitals Health System in Cleveland, Ohio, said in the press release.

While home monitoring of oxygen levels and pulse rates can help patients know when to seek care, he said that, “to be useful, their pulse oximetry data must be accurate, and the accuracy of these devices varies widely.”

The FDA in 2021 issued a statement clarifying that it didn’t review the accuracy of pulse oximeters sold online or at drug stores, highlighting limitations of the devices including difficulty taking measurements when a person is moving, in patients with poor circulation, or in those with darker skin.

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.

Masimo said the newly cleared device uses the company’s Signal Extraction Technology, which hospitals and clinics use to take pulse oxygen readings.

MightySat Medical is intended for adults with normal or poor circulation, to be used while not in motion. Unlike some competing devices, it provides accurate measurements in patients of all skin colors, according to Masimo.

“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,” Kiani said.

The device cannot be used to diagnose or screen for lung diseases, and treatment decisions related to data from the device should always be made by a healthcare provider, the company cautioned.