NEW YORK – Ibex Medical Analytics announced on Thursday that its Galen Prostate platform has received CE marking under the EU's new In Vitro Diagnostic Regulation.
The IVDR became effective in May 2022.
The solution uses artificial intelligence to analyze biopsies before pathologists review them and its algorithms were trained on datasets from multiple pathology institutes that included rare prostatic malignancies, Tel Aviv, Israel-based Ibex said in a statement. The software provides a Gleason score, tumor size, and associated morphologies for each cancer slide, as well as decision support tools to accelerate turnaround time and reduce subjectivity, it added.
The prostate cancer solution, along with the Israeli firm's additional products, Galen Breast and Galen Gastric, originally received CE marking under the EU's previous In Vitro Diagnostic Medical Device Directive and the new IVDR CE mark replaces the previous designation. Ibex added that it received its IVDR CE certificate after a review of the development process, the quality of the product, and its safety and performance. It added that it plans to migrate the breast and gastric cancer solutions to the new IVDR regulations this year.