FDA Authorizes Marketing of MAGENTIQ-COLO™, a Cutting-Edge AI Gastrointestinal Lesion Software Detection System that Helps Detect Lesions in Real Time During Colonoscopy Procedures
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.
- 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.
- To download photos of the MAGENTIQ-COLO™ solution, click here and here .
- 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.
- MAGENTIQ-COLO™ will be marketed in the U.S. through a local subsidiary and a network of agents that is now being established.