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 ...

The FDA designated 166 products under its breakthrough devices program in its most recent financial year, reversing the ...

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

Cad (Nasdaq:ICAD) announced today that the FDA cleared its ProFound Detection version 4.0 for digital breast tomosynthesis ...

The system is designed to shorten scan times, which may be better for people who struggle to stay still or have ...

Zeta Surgical announced that the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities.

Although PAPNET was not widely adopted due to its high costs, the FDA has since approved close to 1,000 AI-based medical devices and products, with applications largely in radiology and cardiology.

AI Medical Advice Risks: 22% Harm Rate with Copilot Use Your email has been sent Study reveals alarming risks of AI medical advice from Copilot and highlights the urgent need for professional ...

A new California law will require a human to sign off on decisions by AI-generated algorithms, while another law requires ...

Startups that build AI medical assistants and medical scribes, which save doctors time that they would otherwise spend taking notes and populating medical records, have been booming over the past ...

But three AI safety advocates made it clear to startup founders that going too fast can lead to ethical issues in the long run. “We are at an inflection point where there are tons of resources ...