Medical AI That Can Learn Forces FDA Rules to Evolve as Well

The technology behind medical devices is advancing much faster than the federal regulations that cover them. This is especially true of cutting-edge devices that incorporate artificial intelligence to detect physical changes and aid in disease detection and diagnoses.

Can’t Keep Up: Some devices use computer algorithms that adapt and change as they are used, and at present the FDA must review every change. This isn’t feasible, device makers say.

Details, Please: An FDA proposal to update regulations has manufacturers recommending that artificial intelligence be better defined and asking for specific examples of algorithms that won’t trigger additional agency review. Ayanna ...