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…