Monday, July 31, 2023
Magentiq-Eye has received US FDA clearance for its MAGENTIQ-COLO™ through the 510(k) process.
The device offers the gastroenterology community and its patients a substantial increase in Adenoma Detection Rate (ADR). The system will now be available in the United States.
A comprehensive study conducted in 2022 across 10 leading medical centres involving 29 endoscopy experts and over 950 enrolled patients validated MAGENTIQ-COLO™ as one of the top-performing artificial intelligence (AI) solutions in its category.
It increased ADR by 26 percent relatively (7 percent in absolute values), leading to a remarkable 21 percent decrease in colourectal cancer (CRC) occurrence and an impressive 35 percent decrease in patient mortality.
Colourectal cancer is the third-leading cause of cancer-related death in the United States, according to the National Institutes of Health (NIH). CRC typically develops from mucosal abnormalities like polyps or other precancerous growths in the colon or rectum, which can be identified during colonoscopy procedures.
Colonoscopy involves th e insertion of an endoscope with a camera at its tip through the rectum, enabling examination along the entire length of the colon to detect abnormalities.
