It’s no secret that AI-powered medical devices are revolutionizing healthcare, setting new standards for speed, precision, ...
As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...
Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...
The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...
Michelle Tarver, MD, PhD, a 15-year veteran of the agency, is stepping into a pivotal role as the new director of the FDA's device division, taking over for Jeffrey Shuren, MD. Dr. Shuren's tenure was ...
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has put out a call for developers of artificial intelligence as a medical device (AIaMD) technology to join its new regulatory ...
The U.S. Food and Drug Administration's ("FDA") new advisory committee on digital health is set to examine its approach for evaluating and ...
Examples range from ambient voice transcription tools that enable doctors or nurses to spend more time with their patients to diagnostic devices ... be seen how medical professionals and patients will ...
People often possess an array of devices that incorporate artificial intelligence ... There are currently no medical tests to definitively diagnose autism, but a recent study demonstrated that ...
With the consistent development of new apps, wearable devices are playing a growing role in monitoring our overall health. KYW medical editor Dr. Brian McDonough has more.
The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary technology. By Christina Jewett There are now artificial intelligence ...