April 12, 2021 | less than a minute read

FDA Approves First AI Device to Detect Colon Lesions

Katten

Were the FDA's ears ringing? Just a day after our Artificial Intelligence and Medical Devices webinar, where we discussed the various applications of artificial intelligence and machine learning to gastroenterology, the FDA approved, through the De Novo premarket review pathway, a groundbreaking device to advance the accuracy of colorectal screenings. With marketing authorization granted to the GI Genius, medical device manufacturers are encouraged to develop and bring to market substantially equivalent devices that have the potential to improve diagnoses and treatment outlooks for patients suffering from gastrointestinal diseases.

Today, the U.S. Food and Drug Administration authorized marketing of the GI Genius, the first device that uses artificial intelligence (AI) based on machine learning to assist clinicians in detecting lesions (such as polyps or suspected tumors) in the colon in real time during a colonoscopy.

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