Ibex Medical Analytics (Ibex) an AI-powered cancer diagnostics specialist, has announced that Galen Prostate is now CE marked under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for supporting pathologists in primary diagnosis of prostate biopsies.
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Tick symbolising approval
IVDR is the new regulatory standard set by the European Union, replacing the previous In Vitro Diagnostic Medical Device Directive (IVDD). The new regulation sets a new bar for product performance and clinical validation, as well as post marketing surveillance. Galen Prostate received its IVDR CE certificate following a review demonstrating the quality of the product and its development process, safety, and performance. During 2023, Ibex plans to migrate additional products, including its Galen Breast and Galen Gastric solutions, under the IVDR certificate.
Dr. Yael Liebes-Peer, head of regulatory affairs and quality assurance at Ibex Medical Analytics, 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.”
To help improve the quality of cancer diagnosis, increase productivity, and optimise pathology workflows, Galen Prostate uses AI to analyse biopsies ahead of pathologists’ review, providing them with diagnostic insights to guide their diagnosis. Galen Prostate’s algorithms were trained on datasets from multiple pathology institutes around the world. Galen helps pathologists diagnose cancer, provides additional insights, including a Gleason score, tumour size and associated morphologies for each cancer slide, and offers decision support tools to help accelerate diagnostic turnaround and reduce subjectivity.
Ibex offers widely deployed AI technology in pathology, supporting pathologists worldwide with augmented diagnostic capabilities during diagnosis of breast, prostate, and gastric biopsies.
