Vara secures CE mark for independent AI mammography reading
A German medical technology company has become the first to receive regulatory approval for artificial intelligence to function as an independent second reader in breast cancer screening and diagnostic mammography across Europe.
Vara’s CE certification for its breast-imaging AI system, enables deployment as a standalone second opinion rather than merely decision support. The approval positions the technology to address critical radiologist shortages affecting national screening programmes throughout Europe.
Clinical evidence from largest real-world AI study
The regulatory milestone builds on findings from the PRAIM study, published in Nature Medicine earlier this year. The prospective, real-world investigation enrolled 460,000 women across 12 German centres with no exclusion criteria, demonstrating statistically significant improvements in cancer detection rates alongside meaningful workload reduction for radiologists.
The study represents the largest prospective evaluation of AI in healthcare to date, processing more than 1.5 million mammograms annually through 40% of Germany’s national screening programme.
Autonomous monitoring enables regulatory approval
“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.”
Regulators specifically recognised Vara’s autonomous, prospective AI monitoring system as a new standard for continuous quality assurance in clinical AI deployment.
Implementation and availability
The CE-marked system is available immediately across Europe, offering integration directly within PACS viewers or via Vara’s proprietary platform. The technology analyses current mammograms alongside images from prior screening rounds.
Deployment as an independent reader within organised national screening programmes will proceed according to individual country guideline processes.
- For more information, visit: https://vara.ai
