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

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

Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device's ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...

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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either ...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 FDA aims to enhance pulse oximeter accuracy for patients of colour by requiring more diverse data in studies. This change ...

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

The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...

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

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

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