The common medical devices don’t work as well for Black patients. The FDA is now trying to do something about it.

Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now the US Food and Drug Administration is proposing guidance to help make ...

The agency outlined what information it would like to see in premarket submissions for medical pulse oximeters, including validation of the devices’ accuracy and ensuring the devices are tested ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far ... s blood oxygen levels, are less accurate on people with darker skin.

Amid research that has shown pulse oximeters underperform on darker skin tones, the FDA on Jan. 6 issued proposed guidance for manufacturers to improve device accuracy. Pulse oximeters ...

Some have criticized the lack of regulation for accuracy surrounding these devices. CEO John Hastings of Plymouth’s Nonin Medical, which launched the fingertip pulse oximeter in 1995 ...

A fingertip pulse oximeter distributed by Concord Health Supply, Inc., a family-owned business in Skokie, is earning praise as the best in class for home use by Wirecutter, The New York Times' popular ...

The Food and Drug Administration’s recommendations apply to pulse oximeters, which are clip-on devices used in hospitals and medical clinics to ensure patients are getting enough oxygen.

and uses an oxygen tank at home. But her request for supplemental oxygen while hospitalized was denied, Starr said, because readings from a pulse oximeter on her finger falsely indicated that she ...

This story was originally published on MedTech Dive. To receive daily news and insights, subscribe to our free daily MedTech Dive newsletter. The Food and Drug Administration on Monday released ...