FDA Grants de novo Clearance for First AI-based CADe System for Colorectal Polyps

Medtronic announced the US FDA has granted de novo clearance for GI Genius, the first and only commercially available computer-aided detection (CADe) system using artificial intelligence (AI) to identify colorectal polyps. The module, compatible with any colonoscope video, uses advanced AI to highlight the presence of precancerous lesions with a visual marker (with a green box) in real-time – serving as an ever vigilant second observer. It processes images using advanced algorithms that can identify and mark abnormalities consistent with polyps, including small flat polyps that might otherwise go undetected by the human eye.

"More than 19 million screening colonoscopies are performed in the United States each year. A key factor in the prevention of colorectal cancer is the integration of leading-edge technologies into gastroenterology practices to increase detection rates," said Dr. James Weber, a gastroenterologist and chief executive officer of the GI Alliance. "Detection of adenomas during colonoscopy is an important quality metric. The addition of AI can increase the quality of colonoscopies, potentially improving diagnosis and outcomes for colon cancer patients."

Colorectal cancer is the third most common form of cancer globally with 1.8 million new cases in 2018¹. Studies have shown that having a second observer can increase polyp detection rates and every 1% increase in adenoma detection rate (ADR) reduces the risk of colorectal cancer by 3%^2,3.Use of the GI Genius module has demonstrated a 14% absolute increase in ADR compared to colonoscopy alone for both flat (42% increase) and polyploid (36% increase) lesions, thus increasing accuracy and reducing the rise of interval cancers which can occur between colonoscopies⁴. 

"Colonoscopies allow highly skilled gastroenterologists to identify polyps and lesions that might develop into cancer. With GI Genius we can tap into the potential of artificial intelligence approaches to increase detection rates. This important new development helps us in our mission to detect colon cancer early and to improve patient outcomes," said Michael Sapienza, chief executive officer of the Colorectal Cancer Alliance.

"Medtronic is committed to preventing colorectal cancer and improving patient outcomes with disruptive technologies that aid screening, increase patient compliance, and improve treatment," said Giovanni Di Napoli, president of the Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic. "With FDA de novo clearance for the GI Genius and its AI capabilities, we expect to enhance and improve colonoscopies and polyp detection. By introducing AI technology into the colonoscopy market, we anticipate improving colonoscopy detection rates and reducing variability in patient outcomes."

Medtronic is the exclusive worldwide distributor of the GI Genius module, which was developed and is manufactured by Cosmo Pharmaceuticals. The GI Genius intelligent endoscopy module received de novo clearance from the U.S. FDA on April 9, 2021. In addition to the United States, the GI Genius module is available in Europe and select markets in Asia, Australia and the Middle East.

1. Estimated number of deaths in 2018 worldwide, both sexes, all ages. Globocan Cancer Data. Published 2018. Accessed Jan 2021.
2. Wang P, Berzin TM, Glissen Brown JR, et al. Gut 2019; 68:1813-1819.
3. Corley DA, Jenson CD, Marks AR JR, et al. NEJM 2014;370:1298-306.
4. Repici, A., Badalamenti, M., Maselli, R., et al. Gastroenterology 2020; doi: https://doi.org/10.1053/j.gastro.2020.04.062.