The device, one of the only artificial intelligence solutions cleared for colonoscopy, will be updated in the future to expand its functionality.
HAIFA, Israel, July 31, 2023 /PRNewswire/ — MAGENTIQ-EYE LTD., an Israeli-based technology company founded in 2014, announced today 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.