Stratipath Breast Achieves CE Marking Under IVDR, Reinforcing Its leading position in AI-Based Breast Cancer Precision Diagnostics
Stratipath, today announced that Stratipath Breast has received CE marking under the In Vitro Diagnostic Regulation (IVDR, EU 2017/746), the EU’s most stringent regulatory framework for in vitro diagnostic medical devices. The certification confirms that Stratipath Breast meets the highest standards for clinical evidence, analytical validity, and post-market surveillance, and marks a natural next step in the product’s regulatory journey.
Stratipath Breast Validated in TAILORx Presented at ASCO 2026
new validation data for prognostic performance of Stratipath Breast in the landmark TAILORx trial will be presented at the American Society of Clinical Oncology (ASCO) Annual Meeting 2026 in Chicago. The data will be presented by Johan Hartman, MD PhD, Professor of Tumour Pathology at Karolinska Institutet and Co-founder of Stratipath.
Helsinki University Hospital adopts Stratipath Breast for AI-based risk profiling in Breast Cancer Care
Helsinki University Hospital (HUS), Finland’s largest healthcare provider and one of the leading academic medical centres in the Nordics, has chosen to implement Stratipath Breast, an AI-based risk profiling solution for breast cancer, as a tool for prognostic testing in its clinical environment.
Stratipath and PathAI Partner to Expand Access to AI-based Precision Diagnostics
Stratipath Breast will be available within PathAI’s AISight® Dx Image Management System (IMS)
Stratipath and Visiopharm partner to advance implementation of AI-Powered Breast Cancer Diagnostics
Stratipath and Visiopharm, today announced a strategic collaboration to combine their regulatory compliant solutions for enhanced breast cancer diagnostics.
Region Östergötland Implements AI-Powered Stratipath Breast to Enhance Breast Cancer Diagnostics
Linköping University Hospital and Region Östergötland have chosen to implement Stratipath Breast as part of their clinical routine for early breast cancer diagnostics.
Region Uppsala chooses to implement AI-based risk profiling with Stratipath Breast
Region Uppsala, Sweden’s fourth largest healthcare region, has chosen to implement Stratipath Breast, an AI-based risk profiling solution for breast cancer, in clinical use.
Stratipath releases biopsy capability for its CE-IVD marked AI diagnostic solution, Stratipath Breast
Stratipath releases biopsy capability for its CE-IVD marked AI diagnostic solution, Stratipath Breast. The new capability strengthens clinical decision-making for neoadjuvant therapy.
Diagnexia and Stratipath Partner to Expand AI-Based Cancer Precision Diagnostics Across the UK and Europe
Diagnexia, and Stratipath AB are pleased to announce a strategic partnership. This collaboration will bring Stratipath Breast, an AI-based prognostic risk profiling tool for invasive breast cancer, to pathology laboratories, hospitals, and healthcare providers across the UK and Europe.
Professor Daniel Hayes Joins Stratipath’s Scientific Advisory Board
Stratipath is proud to announce that globally recognized breast oncologist, Professor Daniel F. Hayes, has joined the company’s Scientific Advisory Board. Professor Hayes will collaborate closely with the board, chaired by Professor Jonas Bergh, to further advance Stratipath’s innovative solutions in breast cancer precision diagnostics.