The new director overseeing medical devices will confront criticisms about hasty approvals as she ushers in revolutionary ...

As the FDA continues to develop and solidify its guidance and regulations on AI, medical device manufacturers should prepare ...

Artificial intelligence (AI) is reshaping industries and our daily lives, from smart devices to healthcare and even the way ...

Over the past decade, FDA approvals of artificial intelligence and machine learning (AI/ML)–enabled medical devices have surged. They reached a ...

Christina JewettThere are now artificial intelligence programs that scan MRIs for signs of cancer, Apple AirPods that work as ...

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 FDA faces policy challenges as technological advances roil health care and the agency fights for resources from Congress — no matter who wins the election.

By Andrew Higgins The new director overseeing medical devices will confront ... Residents say Mr. Musk’s data center for artificial intelligence is compounding their pollution burden and adding ...

The EU AI Act, which went into force on August 1, 2024, introduces specific rules for artificial intelligence (AI) systems, especially those ...

NPR's Ayesha Rascoe speaks with U.S. FDA Commissioner Robert Califf about the agency's process for regulating artificial intelligence in healthcare.

FUJIFILM Philippines is leveraging artificial intelligence (AI) and medical information technology (IT ... Fujifilm Philippines launched its AI-assisted portable X-ray device, FDR Xair, in September.

Investment advisory firm Ithaka Group released the “Ithaka US Growth Strategy” third-quarter 2024 investor letter. A copy of ...