Pathology Diagnostics Platform Meets Safety, Quality and Performance Criteria Under EU’s New In Vitro Diagnostic Medical Devices Regulation
Tel Aviv, Israel – 9th February, 2023 – Ibex Medical Analytics (Ibex), the leader in AI-powered cancer diagnostics, today 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. Galen Prostate is the first standalone AI-based cancer diagnostics product of its kind certified under the IVDR.
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 rigorous review demonstrating the quality of the product and its meticulous 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.
“Ibex continues to maintain the highest possible standards for its products, bringing cutting-edge computational solutions to improve outcomes of cancer care,” said Dr. Yael Liebes-Peer, Head of Regulatory Affairs and Quality Assurance at Ibex Medical Analytics. “Dedicated to our mission of providing every patient with an accurate, timely and personalized 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 optimize pathology workflows, Galen Prostate uses AI to analyze biopsies ahead of pathologists’ review, providing them with diagnostic insights to guide their diagnosis. Galen Prostate’s algorithms were trained on large datasets from multiple pathology institutes around the world, enriched with rare prostatic malignancies. Galen helps pathologists diagnose cancer, provides additional insights, including a Gleason score, tumor size and associated morphologies for each cancer slide, and offers decision support tools to help accelerate diagnostic turnaround and reduce subjectivity.
Ibex offers the most widely deployed AI technology in pathology, supporting pathologists worldwide with augmented diagnostic capabilities during diagnosis of breast, prostate, and gastric biopsies. Improving the diagnostic accuracy, reducing turnaround time, boosting productivity and improving user experience for pathologists, Galen has demonstrated excellent outcomes across multiple clinical studies performed in different pathology labs and diagnostic workflows1,2,3,4,5.
About Ibex Medical Analytics
Ibex Medical Analytics is transforming cancer diagnostics with world-leading clinical grade AI-powered solutions for pathology. Empowering clinicians and supporting pathologists, Ibex is on a mission to provide accurate, timely and personalized cancer diagnosis for every patient. Ibex’s Galen™ is the first and most widely deployed AI-powered platform in pathology. Pathologists worldwide use Galen™ as part of their everyday routine to improve the accuracy of cancer diagnosis, implement comprehensive quality control measures, reduce turnaround times and boost productivity with more efficient workflows. For additional company information, please visit https://ibex-ai.com/ and follow us on LinkedIn and Twitter.
Multiple solutions under the Galen™ platform are CE marked (IVDD) and registered with the UK MHRA. Galen First Read for prostate is now also CE marked under IVDR. The Galen platform includes solutions which are for Research Use Only (RUO) in the United States and not cleared by the FDA. For more information, including indication for use and regulatory approval in other countries, contact Ibex Medical Analytics.
 Pantanowitz et al., An artificial intelligence algorithm for prostate cancer diagnosis in whole slide images of core needle biopsies: a blinded clinical validation and deployment study, THE LANCET Digital Health Aug 2020