The device, one of the only artificial intelligence solutions cleared for colonoscopy, will be updated in the future to expand its functionality
FDA authorises marketing of MAGENTIQ-COLO gastrointestinal lesion software detection system. (Credit: marionbrun from Pixabay)
MAGENTIQ-EYE LTD., an Israeli-based technology company founded in 2014, announced that the U.S. Food and Drug Administration (FDA) has cleared the MAGENTIQ-COLO via the 510(k) process. The device, which offers the gastroenterology community and its patients a significant increase in Adenoma Detection Rate (ADR), will be available in the United States in the coming weeks. The FDA clearance comes on the heels of the European CE Mark and Israel AMAR approval, which were received in mid-2021, opening doors to one of the most significant markets for this category of medical devices.
According to the National Institutes of Health (NIH), colorectal cancer (CRC) ranks as the third-leading cause of cancer-related death in the United States. CRC usually originates from mucosal abnormalities such as polyps or other precancerous growths in the colon or rectum, which can be detected during colonoscopy, a screening and surveillance process that involves inserting an endoscope equipped with a camera at its tip through the rectum and navigating along the entire length of the colon in search of abnormalities.
Although colonoscopy has become the standard of care in most developed countries, with 15 million to 20 million procedures performed annually in the United States alone, high missed rates and undetected adenomas during colonoscopy procedures mean that even patients who are being regularly screened are still at risk of developing colon cancer. A missed polyp can lead to interval cancer, which accounts for approximately 8% to 10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection.
In a comprehensive study performed in 2022 across 10 leading medical centers with 29 endoscopy experts and more than 950 enrolled patients, MAGENTIQ-COLO was validated as one of the best performing artificial intelligence (AI) solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which is translated into a 21% decrease in CRC occurrence and a 35% decrease in patient mortality.
“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,” says Dror Zur, founder and CEO of MAGENTIQ-EYE. “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.”
MAGENTIQ-COLO will be marketed in the U.S. through a local subsidiary and a network of agents that is now being established.
Source: Company Press Release