FDA, skin tone

FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones
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 these devices more reliable and less biased.
FDA Pushes to Improve Blood Oxygen Monitor Accuracy Across Skin Tones
The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with diverse skin tones.
FDA seeks to boost accuracy of blood-oxygen monitors across skin tones
The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their performance across skin tones amid growing evidence that the current ones are not reliable for patients with darker skin.
FDA releases long-awaited guidance to improve accuracy of pulse oximeters for all skin tones
Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either use the newly developed Monk Skin Tone scale or another scale, called the individual typology angle (ITA), which is based on spectrophotometric measurements.
U.S. regulator aims to improve accuracy of blood oxygen devices for range of skin tones
The U.S. Food and Drug Administration proposed new guidance for devices used to monitor blood oxygen levels to improve their accuracy and performance across a range of skin tones.
FDA Proposes Updated Recommendations to Help Improve Performance of Pulse Oximeters Across Skin Tones
Today, the U.S. Food and Drug Administration published new draft guidance aimed at helping improve the accuracy and performance of pulse oximeters

FDA, lead and baby food

New FDA guidance aims to improve accuracy of pulse oximeters for people of color
A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...
FiercePharma2h
FDA looks to clarify confirmatory trial mandate for accelerated approvals
In recent years, the FDA has amped up its supervision of accelerated approvals, including by requiring that confirmatory ...
STAT2h
FDA’s new guidance on AI in drug development centers the risk introduced by the technology
After nearly a decade of machine learning innovations, the FDA has issued its first draft guidance on the use of AI in drug ...
FDA seeks to boost blood oxygen monitor accuracy across skin tones
The U.S. health regulator on Monday proposed a new guidance for widely used blood oxygen monitoring devices to improve their ...
Cheese Puffs Recall as FDA Issues Risk Warning
The snacks were distributed in the state of New York and have been recalled due to undeclared additives and flavor enhancers.
BioPharma Dive9h
5 FDA decisions to watch in the first quarter of 2025
By the end of March, the regulator could clear a highly anticipated pain drug from Vertex and a heart drug that’s critical to Alnylam’s future.
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
Priority review granted for CUTX-101 with PDUFA target action date set for June 30, 2025Cyprium is eligible to receive royalties and up to $129 ...