Ibex Medical Analytics, a leading AI-powered cancer diagnostics company based in Tel Aviv, Israel, has announced that its Galen™ Prostate solution has received CE marking under the In Vitro Diagnostic Medical Devices Regulation (IVDR) for supporting pathologists in the primary diagnosis of prostate biopsies. Galen Prostate is the first standalone AI-based cancer diagnostics product to receive the IVDR certification, demonstrating its safety, quality and performance. Ibex plans to migrate additional products, including Galen Breast and Galen Gastric, under the IVDR certificate. Galen Prostate uses AI to analyze biopsies ahead of pathologists’ review and provides them with diagnostic insights to guide their diagnosis. The product has demonstrated excellent outcomes across multiple clinical studies and is used by pathologists worldwide to improve the accuracy of cancer diagnosis, reduce turnaround times and boost productivity with more efficient workflows.
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