Medtronic plc reported the U.S. Food and Drug Administration (FDA) granted de novo clearance for GI Genius intelligent endoscopy module in the United States.
The GI Genius module is said to be 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, provides physicians with a powerful new solution in the fight against colorectal cancer — the third most common form of cancer globally with 1.8 million new cases in 2018.
"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."
The GI Genius module uses advanced AI to highlight the presence of precancerous lesions with a visual marker 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. 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.
"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.
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.
