Ibex Medical Analytics announced today that it received CE mark approval for its Galen gastric cancer detection solution.
Tel Aviv, Israel-based Ibex uses artificial intelligence (AI) and machine learning technology to power its Galen platform for cancer diagnostics based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology. Galen won CE mark for detecting breast cancer in 2021.
Ibex designed the first-of-its-kind solution as part of the Galen suite to implement AI for the diagnosis of gastric biopsies. The integrated diagnostic solution supports pathologists in the detection of gastric cancer, H. pylori and other important clinical findings while enabling shorter turnaround times and optimized diagnostic workflows.
CE mark approval comes on the heels of results from a blinded, multi-site clinical study at Medipath in France and Maccabi Healthcare Services in Israel in which Galen Gastric demonstrated high accuracy in detecting various types of gastric cancer, as well as H. pylori, neuroendocrine lesions, dysplasia, adenoma and additional pathologies.
“We are proud to obtain this first-of-its-kind CE mark for AI-powered GI diagnostics in pathology, following excellent performance in a multi-site clinical study,” Ibex Medical Analytics co-founder and chief technology officer Chaim Linhart said in the news release. “We trained the Deep Learning models of Galen Gastric on more than a million image samples from multiple labs to ensure it can accurately detect not only cancer but also a multitude of other clinically relevant features that impact future treatment for patients. Ibex now offers an unprecedented breadth of clinical applications, and this approval will enable our growing customer base to expand the usage of AI technology and provide pathologists with new insights as they review gastric biopsies, improving the quality of cancer diagnosis and care.”
In September 2021, Ibex appointed Dr. Douglas Clark as its new chief medical officer and announced that co-founder & CEO Joseph Mossel will relocate to the U.S. to lead its North American expansion efforts from its Boston headquarters.