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.
Unilabs is implementing Stratipath Breast for enhanced breast cancer diagnostics at Capio S:t Göran’s Hospital
Capio St Göran’s Hospital is one of the largest breast cancer clinics in Sweden treating more than 600 breast cancer patients annually. With this new collaboration, Unilabs will use Stratipath Breast on a selected group of these patients.
Unilabs Sverige and St. Göran’s Hospital are soon adopting Stratipath Breast for breast cancer risk profiling.
Johan Hartman is a guest at the Johnson & Johnson podcast “Vi forskar för livet” (“Research for Life”). The episode, titled “Precision Medicine is the Future of Healthcare – But Do We Have the Skills Needed?”