Ibex Medical Receives CE Mark under EU’s IVDR
In accordance with the European Union's (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR), Ibex Medical Analytics' Galen™ Prostate pathology diagnostics platform has obtained the CE mark.
The novel platform was created to help pathologists in making a preliminary prostate biopsy diagnosis.
It is touted as the first standalone cancer diagnostics device powered by artificial intelligence (AI) to receive IVDR certification.
Galen Prostate's algorithms have been trained on sizable datasets from various pathology centers around the world and integrated with rare prostatic malignancies.
The platform uses AI to analyze biopsies prior to pathologist review, improving pathology workflows while increasing productivity and the accuracy of cancer detection.
Galen Prostate provides pathologists with additional information in addition to helping them identify cancer, such as the Gleason score, tumor size, and associated morphologies for each cancer slide.
The platform also offers decision-support tools that lessen subjectivity and hasten the response time for diagnoses.
With its assistance for the diagnosis of breast, prostate, and gastric biopsies, Ibex asserts to provide the most broadly used AI technology in pathology.