FDA Set to Approve 1,000+ Clinical AI Algorithms

FDA Moves Towards Accelerating AI in Healthcare

The Food and Drug Administration (FDA) is poised to approve over 1,000 clinical AI algorithms by the year's end, marking a significant step in the regulation of artificial intelligence within the healthcare sector. Historically, the FDA has not required review for AI integrated into healthcare systems unless it directly impacted patient care. This is changing as the agency acknowledges the blurred lines between clinical and nonclinical systems.