Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...

The U.S. health regulator on Monday proposed new guidelines for widely-used blood oxygen monitoring devices to improve their ...

Shares of the IBD 50's GeneDx surged Monday after the Food and Drug Administration issued guidance about using AI to develop ...

The FDA's draft recommendations for pulse oximeters aims to include clinical studies involving at least 150 participants with ...

Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either ...

The U.S. Food and Drug Administration proposed new guidance for devices used to monitor blood oxygen levels to improve their ...

The FDA aims to enhance pulse oximeter accuracy for patients of colour by requiring more diverse data in studies. This change ...

Acknowledging the disparity in pulse oximetry implicates a $2 billion industry that has faced stricter regulations in recent ...

Federal health officials are proposing changes to make sure medical devices that measure oxygen levels are working for ...

Recognizing the increased use of artificial intelligence in the development of new therapies, the U.S. FDA on Monday released ...

The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...

Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.