FDA Approves First AI Device to Detect Colon Lesions

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.