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

With the usage of AI in medical devices, ethical concerns center on patient health data, safety, and privacy, which adds an ...

Dr. Michelle Tarver, a veteran of the Food and Drug Administration (FDA), has taken charge of the FDA’s device division at a ...

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

After massive developments in large language models in the past two years, the next wave of AI will turn medical devices into ...

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

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

A new AI-enhanced ECG model, AIRE, accurately predicts mortality and heart disease risk, providing clinicians with actionable ...

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

The healthcare sector depends on medical technology advancements, particularly devices used in disease prevention, diagnosis, ...

Flora Bui, the inventor and founder of Acie, draws from her diverse leadership experience in edtech and mental health as she ...

The U.S. Food and Drug Administration announced Tuesday that it has appointed Dr. Michelle Tarver to head its divis ...