Medtronic granted de novo clearance by FDA for intelligent endoscopy module

Medtronic has been granted de novo clearance for the Gi Genius intelligent endoscopy module by the U.S. Food and Drug Administration (FDA). 

The GI Genius module is a computer-aided detection (CADe) system using artificial intelligence (AI) to identify colorectal polyps. The module, compatible with any colonoscope video, provides physicians with a new solution in the fight against colorectal cancer.

Dr. James Weber, a gastroenterologist and chief executive officer of the GI Alliance, said: "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. 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."

Michael Sapienza, chief executive officer of the Colorectal Cancer Alliance, added: "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.”

The GI Genius module uses advanced AI to highlight the presence of precancerous lesions with a visual marker in real-time. 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. 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%. 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 colonoscopies.

Giovanni Di Napoli, president of the Gastrointestinal business, which is part of the Medical Surgical Portfolio at Medtronic, said: "Medtronic is committed to preventing colorectal cancer and improving patient outcomes with disruptive technologies that aid screening, increase patient compliance, and improve treatment. 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."