The U.S. Food and Drug Administration has its hands full making sure medical AI products are safe, efficacious and trustworthy before they hit the market. The rise of ever-more-innovative iterations of the technology—not least generative AI—is only adding to the burden. 

iCardio.ai, co-founded by a cardiologist, is part of the Cedars-Sinai Accelerator program. The startup has already announced new partnerships with Viz.ai, Abbott and others in the cardiac health space. 

Among AI’s most watchful stakeholders are healthcare organizations in need of AI talent and AI talent in need of work in healthcare. Both groups need to keep up with the technology in its present as well as future iterations.

The new policy goes into effect in November, improving Medicare coverage for a technology that has rapidly gained momentum in recent years.

Some 60% of IT professionals and 51% of operational leaders admit they’re reluctant to involve clinicians in software decisions. 

The popular AI chatbot tends to over-order X-rays, prescribe too many antibiotics and admit too many patients to the hospital when compared with a resident emergency department physician. 

The FDA clearly sees significant potential in this new screening software from New York-based AccurKardia.

As 2024 winds down and the number of FDA-approved medical devices packing AI approaches 1,000—the agency had the tally at 950 as of August—the industry finds itself at a “critical inflection point.”