Wednesday, March 2, 2022

FDA Releases Summary of Clinical Effectiveness for PAIGE Prostate Pathology System

Last fall, I covered the FDA de novo clearance of the PAIGE prostate pathology system using artificial intelligence (e.g. here.)

It's a de novo clearance, DEN200080, and the original documents included an FDA press release and an FDA clearance letter.   

Now, the FDA has released a detailed 25-page decision summary of exactly what data was required for the PAIGE marketing authorization, and how FDA evaluated the data.  Find it here:


To see a listing of all De Novo clearances, showing approval letter immediately and summary of effectiveness after a delay, web page here.

See my March 2022 article on the more advanced state of AI in radiology, here.