Iterative Scopes goes a step further with FDA clearance in AI colonoscopy

It’s been a busy year so far for MIT artificial intelligence spinout Iterative Scopes. After raising $150 million in January, the company has now secured an FDA clearance for computer vision tech that helps spot suspicious polyps during a colonoscopy.

The Skout system works in real time to recognize and highlight potentially cancerous tissues within the video feed a gastroenterologist takes. In a randomized clinical trial of more than 1,350 participants, the system showed it could help improve the number of findings compared to standard procedures and without a significant increase in the number of unnecessary biopsies.

“Even among the best endoscopists, there is room for improvement in adenoma detection, which can impact patient outcomes,” Iterative Scopes’ vice president of clinical operations, Sloane Allebes Phillips, said in a release. “We are enthusiastic about the fact that even gastroenterologists with an already high baseline rate of adenoma detection demonstrated an improvement with Skout.”

In the study, Skout posted a 27% increase in the number of potentially precancerous adenomas found per colonoscopy by drawing a box around them on the screen, for an average of one additional adenoma for every 4.5 patients examined. The program received a CE mark in Europe in 2021.

Last year, Iterative Scopes tapped Provation, a cloud-based provider of clinical documentation support programs, to serve as the exclusive distributor of Skout to academic centers, health systems and gastroenterology-focused practices.

And this past June, the Cambridge, Massachusetts-based company brought on Aditya Khosla, former co-founder of the digital pathology company and Fierce 15 winner PathAI, to serve as its chief technology officer. 

A similar system received an FDA green light in April 2021: the GI Genius program developed by Cosmo Pharmaceuticals and distributed internationally by Medtronic. Like Skout, the add-on video system highlights areas of interest with the goal of finding cancer and pre-cancer when they may be easier to treat.