FDA Authorizes Marketing For AI Gastrointestinal Lesion Software Detection System

The FDA granted 510(k) clearance to the Magentiq-Colo, a device that uses AI-powered software to provide real-time assistance during colonoscopies. The software is expected to be available in the United States during the third quarter of 2023.

The program, developed by Magentiq-Eye Ltd., can help reduce the number of missed polyps during cancer screenings. A missed polyp or lesion during a screening can result in a patient not being diagnosed properly, and potentially not realizing that they have cancer until the disease has further advanced.

In a press release, Magentiq-Eye’s founder and CEO Dror Vur said, “FDA clearance is a major milestone, and we are very proud to join only a handful of companies in the field of AI-aided colonoscopy to be granted clearance. Our next step will be to pursue opportunities in the U.S. market as we look forward to increasing the accuracy of detecting early signs of CRC and taking part in saving the lives of thousands of Americans. Although the sense of accomplishment is strong, I believe this is only the tip of the iceberg for AI in gastroenterology, so stay tuned for new products and features from us coming soon.”