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:
https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN200080.pdf
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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.
