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

As an emergency medicine physician, Dr. Owais Durrani sees this issue regularly first-hand: When he clamps a pulse oximeter onto a patient's fingertip to measure their blood oxygen levels, the small ...

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 ...

Please provide your email address to receive an email when new articles are posted on . The FDA’s proposed changes to premarket pulse oximeter trial criteria were generally accepted by an advisory ...

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 The draft guidance follows years of discussion about concerns that the devices can be ...

The longstanding problem of pulse oximeters providing less-accurate readings for people with dark skin tones got another look Friday from a panel of experts for the US Food and Drug Administration.

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 – ...

“Since the convening, however, pulse oximeters continue to be sold without clear warning labels or other guidance to protect individuals from harm,” the letter said. “We, the undersigned Attorneys ...

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