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

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 ...

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

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.

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

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

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

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 ...

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 ...

A China-Pakistan joint Artificial Intelligence medical diagnosis lab has started working in the ... a Chinese medical technology company that provided three cervical cancer screening devices along ...

Cybercriminals are leveraging Artificial Intelligence (AI ... They help protect devices connected to enterprise networks by using AI to proactively detect, investigate, remove, and remediate ...

A Florida mother filed a lawsuit Tuesday claiming the artificial intelligence company Character.AI allegedly caused the suicide of her 14-year-old son.