New FDA rules to cut racial bias in some, but not all, devices to measure oxygen in the blood
At a CVS store in a racially diverse neighborhood in Brooklyn Center, the only devices available to shoppers to measure their ...
STAT14h
FDA pushes makers of AI devices to disclose more details on testing, performance
The FDA wants the developers of medical devices that rely on AI to disclose more detail about how their devices were ...
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No-Implant Shunt Wins FDA Breakthrough Status for Heart Failure
The new approach is designed to create a connection between the left and right atrial chambers of the heart in a single ...
FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker skin tones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 ...
FDA issues first draft guidance on use of AI in drug, medical device development
Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...
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 ...
WTKR2d
FDA calling on pulse oximeter makers to make life-saving changes to devices
Pulse oximeters help doctors evaluate a person's pulse rate and the oxygen saturation of your blood. The FDA is proposing ...
Advocates urging FDA to ban shock device used in Mass. school ASAP
There's an urgent push underway to get the U.S. Food and Drug Administration to finally ban the devices that administer electric shocks to disabled students at the Judge Rotenberg Center in Canton.
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CBD Tampon Maker Pulls Products Off U.S. Market Following FDA Warning Letter
On the heels of a Food and Drug Administration (FDA) warning letter to the manufacturer of CBD-coated tampons marketed to ...
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FDA issues draft guidance on marketing submissions for AI-enabled medical devices
The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...
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FDA Issues Draft Guidance on AI-Enabled Medical Devices
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices.