At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
New draft guidelines would increase the number of people with darker skin who should be included in clinical trials of the ...
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...
Following the FDA’s release of a guidance requesting more diversity in pulse oximeter testing, the number of clearance ...
Manufacturers increasingly but still infrequently follow Food and Drug Administration guidance that recommends testing pulse oximeters on participants with a range of skin pigmentations, according to ...
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
The agency is proposing that device manufacturers improve their testing to including larger, more diverse sample sizes.
These devices, crucial for measuring blood oxygen levels, have shown discrepancies in accuracy when used on darker skin, leading to potential health risks for non-white patients, the study states ...
Pulse Oximeters May Misread Oxygen Levels in People of Color. the FDA Wants to Change That WASHINGTON (AP) — Makers of medical devices that quickly measure oxygen levels in the blood would have ...
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 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.