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.
The U.S. Food and Drug Administration on Monday proposed new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones.
Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their products work for patients of color, under a new federal proposal ...