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