Ibex Medical Analytics has received CE mark for its pathology diagnostics platform, Galen Prostate, under the European Union’s (EU) In Vitro Diagnostic Medical Devices Regulation (IVDR).

The new platform has been developed to help pathologists conduct a primary diagnosis of prostate biopsies.

It is claimed to be the first standalone artificial intelligence (AI) powered cancer diagnostics product of its type to be certified under the IVDR. 

Integrated with rare prostatic malignancies, Galen Prostate’s algorithms have been trained on large datasets from multiple pathology institutes across the world.

The platform deploys AI to analyse biopsies ahead of pathologist review, thereby helping to boost productivity as well as the quality of cancer diagnosis while optimising pathology workflows.

As well as enabling pathologists to diagnose cancer, Galen Prostate offers additional insights, including Gleason score, tumour size and related morphologies for every cancer slide.

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Furthermore, the platform provides decision support tools that help speed up diagnostic turnaround and lower subjectivity.

Ibex Medical Analytics regulatory affairs and quality assurance head Dr Yael Liebes-Peer said: “Ibex continues to maintain the highest possible standards for its products, bringing cutting-edge computational solutions to improve outcomes of cancer care.

“Dedicated to our mission of providing every patient with an accurate, timely and personalised cancer diagnosis, we are proud to provide the market’s first IVDR-certified product, elevating the quality of diagnosis for patients, pathologists and laboratories.” 

Ibex claims to offer the most widely deployed AI technology in pathology, supporting the diagnosis of breast, prostate and gastric biopsies.