Medtronic Targets GI Endoscopy With AI-Based Device

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ARTICLE SUMMARY:

Artificial intelligence is branching into video endoscopy and could help level the playing field for patients with a number of GI disorders. Among the companies leading the way are Medtronic, Iterative Scopes, and Odin Vision. Excerpted from our recent MedTech Strategist article, AI Makes Waves in Gastroenterology.

There are several companies now targeting GI endoscopy with AI-based assistive tools. Leading the way in the US is Medtronic plc, which has exclusive global distribution rights to the first FDA-approved device in this category, the GI Genius, developed by Dublin-based Cosmo Pharmaceuticals NV. According to Giovanni Di Napoli, president of Medtronic’s gastrointestinal device business, Medtronic has a multiyear partnership agreement with Cosmo, covering both sales/marketing and R&D, and intends to use the GI Genius brand and technology across its entire GI device portfolio.

GI Genius gained FDA de novo approval in April 2021 as a computer-aided detection (CADe) device; it is indicated for use during colonoscopy to help physicians detect cancerous and precancerous polyps. (It is also CE marked and is available in Europe and select markets in Asia, Australia, and the Middle East.)

The device consists of a box containing a data processing module and software that connects to the existing endoscope video processor and display monitor in the endoscopy suite. The system’s machine-learning polyp-detection software runs in real time during the colonoscopy procedure, highlighting suspicious tissue using a bounding box image that is superimposed on the endoscope camera video. The system is scope-agnostic and fits well with current workflow, Di Napoli says.

As mentioned, Medtronic intends to incorporate GI Genius across its entire GI product portfolio. According to Di Napoli, the technology will first be integrated with Medtronic’s PillCam devices, swallowable cameras that take pictures as they travel through the entire length of the bowel to aid in the detection of intestinal bleeding and other GI disorders. By integrating the two technologies, images of bleeding or lesions detected by PillCam can be sent to GI Genius in the endoscopy suite to help the physician locate the area for treatment, something that Di Napoli says is often difficult today.

The company is already working to combine GI Genius with its PillCam Small Bowel device, and over time also plans to integrate the AI technology with other PillCam devices, including PillCam Colon, which is not yet FDA approved for colon cancer screening, and PillCam Crohn’s.

Medtronic also hopes to eventually have FDA approval for GI Genius not only for computer-aided detection (CADe) but also for computer-aided diagnosis (CADx). In Europe, the GI Genius CRC colonoscopy system is already approved and marketed for CADx use, Di Napoli says, and it provides not only a bounding box identifying suspicious tissue, but also tissue characterization that classifies the identified tissue as an adenoma or not an adenoma.

Di Napoli admits that the AI business model is somewhat unconventional for Medtronic, and for traditional medtechs in general. Even though Medtronic is widely identified as a medical device company, “We don’t want to be seen as a scope company; we don’t want to compete with them,” he asserts. “We are in a very different position with GI Genius, which is scope agnostic. But we have other technologies that can communicate with and work with GI Genius to help improve patient outcomes in the endoscopy suite. So it’s a very different business model and a very different vision compared to selling a scope with AI inside. We are selling a platform that’s going to open up options to improve diagnosis, early detection, and early treatment.”

Excerpted from “AI Makes Waves in Gastroenterology; Can it Help Democratize Care?” MedTech Strategist, July 14, 2022.

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