Vara has received the CE Mark for its new breast-imaging artificial intelligence (AI) software, the first to act as an independent second reader for both screening and diagnostic use.

The authorization occurs 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. 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 now available in Europe 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 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, according to the company.

“Our ambition has always been to pioneer data-driven AI at a nationwide scale,” Vara Co-Founder/Chief Technology Officer Stefan Bunk said. “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 in healthcare.”

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 about 40% of screening centers, processing roughly 150,000 mammograms monthly, and more than 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.