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

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

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 ...

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

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.

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

GenAI’s role in driving efficiencies in radiology, the role of videogames as medical tools, thematic take: AI in the ...

Thanks to the implementation of Artificial Intelligence, it is now possible to analyze the ... such as wearables, smart sensors, and medical devices that integrate advanced functionality. Broadcom ...

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 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 ...

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 ...