Press release, Stockholm, Sweden, – Stratipath, a pioneer in AI-based precision diagnostics, 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 was the first AI-based solution for prognostic risk profiling of breast cancer to receive CE-IVDD marking in 2022. The transition to IVDR demands substantially more rigorous clinical documentation, continuous performance monitoring, and independent notified body review than its predecessor. Achieving this certification reflects the depth of scientific validation and regulatory diligence that has underpinned Stratipath Breast since its inception.
“This certification is the result of years of rigorous scientific work, continuous clinical validation, and a disciplined approach to regulatory compliance,” said Fredrik Wetterhall, CEO of Stratipath. “This is not just a regulatory milestone, it is a testament to the strength of our scientific foundation and our commitment to delivering tools that clinicians and patients can trust.”
Stratipath Breast has been in clinical routine use since 2023 and the solution delivers results within one hour, supporting time-critical decisions at the tumour board, and provides an accessible, cost-effective alternative to traditional gene expression tests. With IVDR certification now in place, Stratipath is well-positioned to accelerate adoption across the European market where compliance with the new regulatory standard is increasingly expected.
“For healthcare providers, IVDR certification matters,” said Prof. Johan Hartman, Chief Medical Officer and Co-founder of Stratipath. “It means that the evidence behind a product has been independently scrutinised to the highest standard. For Stratipath Breast, this certification confirms what our clinical partners have experienced, that this is a scientifically grounded, rigorously validated tool ready for routine clinical use.”
This milestone further strengthens Stratipath’s position as a trusted partner for healthcare providers, oncology clinics and pathology departments navigating the transition to AI-enhanced diagnostics and underlines the company’s ambition to make precision diagnostics accessible to more patients across Europe and globally.