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, the company states.

“This certification is the result of years of rigorous scientific work, continuous clinical validation, and a disciplined approach to regulatory compliance,” says 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.”