NEW YORK – Ibex Medical Analytics said Wednesday that it has received CE marking for Galen Gastric, software that applies artificial intelligence to help pathologists detect gastric cancers.
The software, part of the Israeli company's Galen suite of AI-powered pathology technology, is a digital assistant for pathologists, according to an Ibex spokesperson. Galen Gastric, which has been trained on more than 1 million digital pathology images, can help identify gastric cancer, Helicobacter pylori, and signs of ailments including dysplasia, lymphoma, and gastritis.
"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 their pathologists with new insights as they review gastric biopsies, improving the quality of cancer diagnosis and care," Ibex Cofounder and CTO Chaim Linhart said in a statement.
The Galen platform received a CE mark in 2021 for breast and prostate cancer. It also received breakthrough device designation by the US Food and Drug Administration last year.