DeepBio Obtains European CE-IVDD Certification for AI-Based Prostate Cancer Diagnostic Support Software

[Asia Economy Reporter Lee Gwan-joo] DeepBio announced on the 8th that its AI-based prostate cancer diagnostic support software, 'DeepDx Prostate,' has obtained the European medical device certification (CE-IVDD).

This program analyzes whole slide images (WSI) of prostate needle biopsy tissues stained with Hematoxylin & Eosin using artificial intelligence to identify cancerous areas and distinguish severity levels, thereby assisting in cancer diagnosis.

The analysis results are provided according to the Gleason grading system, the most widely used method for differentiating the differentiation degree of prostate cancer tissues, including Gleason patterns 3, 4, and 5, Gleason scores, and five Gleason grades. It automatically measures the proportion of cancer within the entire tissue, the proportion of each Gleason pattern area, and the lengths of tissue and cancer areas, helping to improve diagnostic accuracy.

With this CE certification, DeepBio can now supply the product in Europe as well. Sunwoo Kim, CEO of DeepBio, said, “This CE-IVDD certification has become an opportunity to demonstrate the expertise and confidence of DeepBio’s technology,” adding, “Based on significant research results shared at global academic conferences such as the United States and Canadian Academy of Pathology (USCAP) and the American Association for Cancer Research (AACR), we will actively expand our overseas market channels.”

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