FDA grants De Novo clearance for AI system for colonoscopy, Medtronic's GI Genius intelligent endoscopy module

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FDA grants De Novo clearance for AI system for colonoscopy, Medtronic's GI Genius intelligent endoscopy module

Press releases may be edited for formatting or style | April 12, 2021 Endoscopy
DUBLIN, April 12, 2021 /PRNewswire/ -- Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced 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 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 2018.1

"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."

"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.

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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%.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 colonoscopies.4

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