A long-awaited study commissioned by the FDA has muddied the path forward on how to reduce racial bias in pulse oximeter ...

WASHINGTON, D.C. – The Food and Drug Administration (FDA) is warning that the pulse oximeters that have become essential tools in the fight against COVID-19 may not work as well on people of color. A ...

"Although absolute differences in readings were small, they can result in substantially higher rates of false negatives and ...

The Food and Drug Administration (FDA) held a meeting on Tuesday to examine and discuss what an agency panel called “mounting real-world evidence” suggesting that pulse oximeter devices do not provide ...

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 The draft guidance follows years of discussion about concerns that the devices can be ...

In a suit filed against CVS, Walgreens, GE Healthcare and many other medical technology companies and sellers of pulse oximeters – devices that use light to measure oxygen saturation in the blood – ...

Anil Oza is a general assignment reporter at STAT focused on the NIH and health equity. You can reach him on Signal at aniloza.16. In 2022, Noha Aboelata noticed something troubling. The founding CEO ...

(CNN) — 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 ...

Efforts to fix bias and accuracy problems with pulse oximeters have an uncertain future under the Trump administration. After years of concerns that pulse oximeters may provide less accurate results ...

The doctors and nurses didn’t believe Tomisa Starr was having trouble breathing. Two years ago, Starr, 61, of Sacramento, California, was in the hospital for a spike in her blood pressure. She has ...