Vara earns CE mark as the only AI authorized for an independent second read in mammography, and expands in Europe

BERLIN, Oct. 15, 2025 (GLOBE NEWSWIRE) -- Vara announced today it received a new CE certificate for its new breast-imaging AI – the only on the market allowed to operate as an independent second reader for both screening and diagnostic use. It marks the company’s entry into the European market.

This milestone comes at a critical moment. National screening programs in Europe face mounting radiologist shortages, as well as aging populations and expanded age ranges that demand even more expert time. Vara’s CE mark affirms the safety and clinical evidence for AI as a second reader.

Beyond screening, Vara’s independent read delivers immediate value for providers – particularly in diagnostic workflows where maintaining a human second read is often not economically feasible.

The CE-marked product is available in Europe starting today, as an independent second read or decision support system including analysis of mammograms from prior screening rounds. Providers can integrate Vara directly in their PACS viewer or via the Vara platform – the latter of which currently serves 40% of the German national screening program.

Nature Medicine’s publication of the landmark PRAIM 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: 460,000 women enrolled across Germany, demonstrating statistically significant superiority in cancer detection rate and meaningful workload reduction for radiologists.

In approving Vara's AI for independent second reading, regulators also recognized Vara’s autonomous, prospective AI monitoring, which is setting a new standard for responsible, real-time quality assurance.

“Our ambition has always been to pioneer data-driven AI at a nationwide scale,” said Stefan Bunk, co-founder and CTO of Vara. “The industry has long moved beyond retrospective evidence. Now, by pairing population-wide, real-world results with automatic real-time monitoring, we’re offering a credible, scalable path for AI as an independent reader – and we’re grateful the regulator acknowledged this approach.”

About Vara: Vara builds AI and cloud workflow tools for breast imaging, helping radiologists detect cancer earlier while reducing unnecessary recalls and reading time. In Germany’s national screening program, Vara supports ~40% of screening centers, processing ~150,000 mammograms monthly and >1.5 million annually. PRAIM – with 460,000 participants, 12 centers, and no exclusion criteria – was published in Nature Medicine (2025) and is the largest prospective real-world study of AI in healthcare.

Media contact: Anja Richter – press@vara.ai

Notes to editors: Deployment of the independent-reader role in organized screening programs will proceed subject to national guideline alignment. While Vara’s CE certificate authorizes the capability, program-level adoption follows established guideline processes.