Artificial intelligence

AMIA calls on FDA to refine its AI regulatory framework

reprint The American Medical Informatics Association wants the Food and Drug Administration to improve its conceptual approach to regulating medical devices that leverage self-updating artificial intelligence algorithms. The FDA sees tremendous potential in healthcare for AI algorithms that continually evolve—called “adaptive” or “continuously learning” algorithms—that don’t need manual modification to Czytaj więcej…

Artificial intelligence

AI diagnostic gets FDA Breakthrough Device designation

reprint A Mount Sinai Health System startup, seeking to commercialize an artificial intelligence-enabled clinical diagnostic for kidney disease, has been granted priority regulatory review by the Food and Drug Administration. The FDA has designated RenalytixAI’s KidneyIntelX as a Breakthrough Device, effectively fast-tracking its development, assessment and review. The agency’s Breakthrough Czytaj więcej…