Used during a standard colonoscopy, the newly FDA-cleared EndoScreener software relies on deep learning artificial intelligence to identify potentially precancerous polyps that have formed on the lining of the colon. ( peterschreiber.media)
One down, one to go. After locking down its first FDA clearance, Wision A.I. is already lining up its next regulatory score.
The first authorization was granted to EndoScreener, an artificial intelligence software system that aims to identify potentially precancerous polyps during a colonoscopy. Next up, the Shanghai-based company said it’s preparing an FDA pre-submission for another AI-based tool that looks for colon polyps with high-grade dysplasia in tissue sample slides.
“Obtaining 510(k) clearance from the FDA for EndoScreener and initiating a U.S.-based investigational validation of the new tool for histopathological diagnosis demonstrates how our broadened, enriched AI portfolio can help to reduce colorectal cancer and improve patient outcomes,” said JingJia Liu, Wision’s co-founder and CEO.
