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 Food and Drug Administration on Monday bolstered its recommendations for pulse oximeter testing following public uproar over how inaccurate readings led to different medical care for patients ...
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more clinical data to show the devices accurately work across a range of skin tones.
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 on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can ...
FILE - A health worker uses a pulse oximeter to check the oxygen saturation level of another after administering COVID-19 vaccine at a hospital in Gauhati, India, Jan. 21, 2021. (AP Photo/Anupam ...
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 ...
Jan. 6, 2025 /PRNewswire/ -- Today, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters – important ...