Vara Secures CE Mark as the Sole AI Approved for Independent Mammography Second Reading, Expanding in Europe
BERLIN, Oct. 15, 2025 — Vara today announced it has been awarded a new CE certificate for its innovative breast-imaging AI. This AI is the only one currently available that can function as an independent second reader for both screening and diagnostic purposes. This certification marks Vara’s expansion into the European market.
This achievement arrives at a crucial time, as European national screening programs are facing increasing shortages of radiologists, alongside aging populations and wider age ranges requiring even more expert time. Vara’s CE mark validates the safety and clinical effectiveness of using AI as a second reader.
Beyond screening, Vara’s independent analysis provides immediate benefits for healthcare providers, particularly in diagnostic workflows where maintaining a human second read is often not economically viable.
The CE-marked product is available in Europe starting today, functioning either as an independent second reader or as a decision support system, including the analysis of mammograms from previous screening rounds. Providers can integrate Vara directly into their PACS viewer or through the Vara platform, which currently supports 40% of the German national screening program.
The publication in Nature Medicine of the PRAIM study—a landmark study initiated by Vara—earlier this year made the company’s pioneering efforts as an independent reader possible. PRAIM is the world’s largest prospective, real-world study of AI in healthcare, enrolling 460,000 women across Germany and demonstrating statistically significant improvements in cancer detection rates and considerable workload reduction for radiologists.
In approving Vara’s AI for independent second reading, regulators also acknowledged Vara’s autonomous, prospective AI monitoring, which is establishing a new benchmark for responsible, real-time quality control.
“Our goal has always been to pioneer data-driven AI on a national scale,” stated Stefan Bunk, co-founder and CTO of Vara. “The industry has progressed beyond retrospective evidence. Now, by combining population-wide, real-world results with automatic real-time monitoring, we are providing a reliable, scalable solution for AI as an independent reader, and we are grateful that the regulator recognized this approach.”
About Vara: Vara develops AI and cloud-based workflow tools for breast imaging, assisting radiologists in earlier cancer detection while reducing unnecessary recalls and reading time. Vara supports approximately 40% of screening centers in Germany’s national screening program, processing around 150,000 mammograms each month and over 1.5 million annually. PRAIM, involving 460,000 participants across 12 centers with no exclusion criteria, was published in Nature Medicine (2025) and stands as the largest prospective real-world study of AI in healthcare.
Media contact: Anja Richter – press@vara.ai
Notes to editors: The implementation of the independent-reader role in organized screening programs will be subject to alignment with national guidelines. While Vara’s CE certificate authorizes the capability, program-level adoption will follow established guideline processes.
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