FDA issues draft guidance to improve accuracy of pulse oximeters for people with darker ...
Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...
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 ...
FDA issues first draft guidance on use of AI in drug, medical device development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 ...
STAT3 小时
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Rather than relying on those testing the devices to judge skin tones, the draft guidance suggests manufacturers should either ...
IBD 50's GeneDx Adds To Nearly 2,700% Sprint With FDA Guide On AI
Shares of the IBD 50's GeneDx surged Monday after the Food and Drug Administration issued guidance about using AI to develop ...
Pulse oximeters may misread oxygen levels in people of color. The FDA wants to change that
Makers of medical devices that quickly measure oxygen levels in the blood would have to gather extra data to show that their ...
Modern Healthcare5 小时
FDA drafts guidance for AI developers
The agency announced Monday it was issuing draft guidance that will assist developers as they work through life cycle of ...
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 ...
MassDevice6 小时
Integra Lifesciences receives FDA warning letter for quality systems issues at three locations
Integra Lifesciences recently received an FDA warning letter pertaining to quality systems issues at several facilities.
Oneindia3 小时
FDA Proposes New Guidelines to Ensure Pulse Oximeters Accurately Measure Oxygen Levels in ...
The FDA aims to enhance pulse oximeter accuracy for patients of colour by requiring more diverse data in studies. This change ...
FDA Issues Comprehensive Draft Guidance for Developers of Artificial Intelligence-Enabled ...
Today, the U.S. Food and Drug Administration issued draft guidance that includes recommendations to support development and marketing of safe and effective AI-enabled devices throughout the device's ...
FDA 510(K) Approved Facilities: Increasing GMP Inspections And Compliance Requirements
Indian medical device manufacturers are enhancing GMP compliance and embracing proactive strategies to meet rising USFDA inspections and global healthcare standards, driven by geopolitical shifts and ...