A provocative new proposal has offered the FDA a way to let a broad swath of potentially risky AI devices flood the market.

The FDA continuously updates its list of devices that utilize AI and machine learning (ML) technologies, which has shown exponential growth since 2018. Algorithms for stroke, breast cancer, and lung ...

"The product was arguably safer before integrating changes in the software to incorporate artificial intelligence." The post ...

Rick Abramson, formerly a chief medical officer at a subsidiary of Harrison.ai, which develops AI products to interpret ...

Integra says there is no credible evidence to show any causal connection between TruDi, AI, and any alleged injuries. More ...