Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
The FDA announced its draft guidance on recommendations for studies assessing pulse oximeters to ensure the devices perform ...
Acknowledging the disparity in pulse oximetry implicates a $2 billion industry that has faced stricter regulations in recent ...
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
Manufacturers increasingly but still infrequently follow FDA guidance that recommends testing pulse oximeters on participants ...
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
Darker skin tones are typically the result of the presence of more of the pigment melanin, which can interfere with the absorption of light from the pulse oximeter. In practical terms, this means that ...
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should use ...
Ophthalmology Times - ophthalmology news, articles, and events in a timely and accurate manner for members of the ophthalmic ...
The draft guidance will be open for comment for 60 days. Pulse oximetry is a non-invasive way of measuring blood oxygen ...
Masimo Corp. and Apple Inc. have filed dueling post-trial briefs in a California federal court, following a retrial over ...