The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

California has moved assertively to legislate guardrails around AI in healthcare. Will other states follow? 

Healthcare AI agents can be classified as one of four models. In increasing order of autonomy and clinical integration, these are: foundation, assistant, partner and pioneer. 

Using a left radial artery approach in the cath lab exposes interventional cardiologists to significantly less radiation than a hyper-adducted right radial artery approach. The difference is substantial enough for researchers to declare LRA "the primary access site for cardiac catheterization."

Breast artery calcifications are already visible when radiologists review mammograms, but nothing typically happens with them. Researchers aimed to see if AI could help translate those findings into an easy-to-understand cardiovascular risk score.

One product is being pulled from the market, and the other is receiving updated instructions for use.

Unionized nurses: ‘AI overrides our expertise and degrades the quality of care.’ 

AI has a long way to go before it meaningfully closes disparities in healthcare access and delivery. In fact, even when aimed at that goal, the technology can backfire.