AI-based cancer diagnostics solutions provider Ibex Medical Analytics has received a CE mark for its gastric cancer detection solution, Galen Gastric.
Galen Gastric is an integrated diagnostics tool that helps pathologists detect gastric cancer, H. pylori, and other significant clinical findings in fast turnaround times and with better diagnostic workflows.
A team of pathologists, data scientists, and software engineers created the solution using advanced Deep Learning technologies and trained algorithms on more than a million picture samples.
The CE mark follows findings from blinded, multi-site clinical research conducted at Medipath, France’s pathology network, and Israel’s Maccabi Healthcare Services.
Galen Gastric has shown to be accurate in diagnosing several forms of stomach cancer, as well as Helicobacter pylori, neuroendocrine tumours, dysplasia, adenoma, and other illnesses.
Ibex said that the findings from the study support the Galen Gastric’s robustness and its use by pathology institutes looking to increase diagnostic quality and productivity.
Ibex Medical Analytics co-founder and CTO Chaim Linhart said: “We are proud to obtain this first-of-its-kind CE-Mark for AI-powered GI diagnostics in pathology, following an excellent performance in a multi-site clinical study.
“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 their pathologists with new insights as they review gastric biopsies, improving the quality of cancer diagnosis and care.”
With the introduction of the first-of-its-kind solution, Ibex now has a wide range of AI solutions in pathology to identify cancer and other diseases.
Ibex now partners with laboratories, hospitals, and health systems to apply AI for the diagnosis of stomach biopsies using the Galen suite of products, which is a common AI technology in pathology.