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.
First world health tech: Press Release Stratipath releases biopsy capability for its CE-IVD marked AI diagnostic solution, Stratipath Breast

First world health tech: Press Release Stratipath releases biopsy capability for its CE-IVD marked AI diagnostic solution, Stratipath Breast
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.
ESMO daily: AI integration in breast cancer – a long way ahead?

The ESMO Daily Reporter recently published a summary of the insightful discussions on AI in oncology, a field that is transforming rapidly. Our very own co-founder and CTO, Dr. Mattias Rantalainen, chaired and contributed to this important track.
Stratipath team contributes to foundation model research published in Nature

A method for spatial interpretation of weakly supervised deep learning models in computational pathology
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.