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Company hopes to secure FDA approval in 2022, to begin selling in U.S. market

MIT spinout Iterative Scopes has submitted its advanced polyp detection tool, SKOUT, to the U.S. Food and Drug Administration (FDA) for 501(k) clearance review and approval. The company, which is quickly emerging as a market leader, works to bring AI and other software into gastroenterology, with a current focus on inflammatory bowel disease and colorectal cancer prevention, according to an article from Yahoo News.

SKOUT is an advanced automated polyp detection software designed to standardize insights from endoscopic videos. The product’s unique ability to identify and document suspicious lesions and polyps in real time aims to reduce human error and improve patient outcomes during routine colonoscopy procedures. According to the Iterative Scopes website, the SKOUT software can be easily integrated with a GI physician’s current scope and monitor, eliminating the need for investment into newer equipment.

“We have trained our model on thousands of patient videos to ensure that our software can detect even the most difficult adenomas,” the Iterative Scopes website states.

The company has also partnered with Provation to help reduce time spent on post-procedure processes.

“Currently gastroenterologists spend significant time filling out post-procedure documentation,” the company’s website says. “This includes logging start and end times of procedures, timestamps of reaching anatomical landmarks, summarizing biopsy/resection procedures and bowel prep scores. Based on the similar computer vision technology deployed in the endoscopy suite, Iterative Scopes has partnered with Provation to develop an AI-enabled documentation integration that aims to decrease post-procedure documentation time by 50% in the next two years.”

Iterative Scopes is not the first company to bring this technology into the industry, as the FDA approved its first ever plug-in AI colonoscopy system, GI Genius, in April 2021, according to Fierce Biotech.

As AI continues to grow within the GI industry, physicians will see improvements in the efficiency and accuracy of routine procedures. These upgrades will in turn improve patient outcomes, and the costs associated with common forms of care.

Iterative Scopes hopes to see the completion of its 501(k) review later this year.