Vara, the AI company powering more than half of Germany’s organized breast cancer screening program, today received CE class 2b marking under EU MDR for its tomosynthesis (3D mammography) AI solution.
European screening is at an inflection point, driven by new national guidelines and large screening tenders across the continent. Vara is the only AI provider proven to operate at national scale, demonstrated by PRAIM, the world’s largest prospective study published in Nature Medicine in 2025. Vara’s comprehensive solution for program-wide AI adoption includes the industry-leading multi-prior model, real-time performance monitoring and the regulatory scope as concurrent and independent reader to relieve the radiologist workload while improving program quality.
As screening programs increasingly integrate tomosynthesis into their clinical routine, Vara now underlines its commitment to the future of screening.
A different company than 1 year ago
Within only 12 months after the publication of the PRAIM study in Nature Medicine, Vara expanded its presence from Germany to 10+ European countries and signed major distribution partnerships – including DeepC, Sectra Amplifier, Quibim or Medical Horizons.
The regulatory approval for the tomosynthesis product follows other major releases within the last year, including the CE approval for Vara’s independent second reader product and the commercial launch of Vara’s 3-prior AI model. Further announcements are expected over the coming months, including Vara’s breast cancer risk prediction.
“Speed is what European screening programs need to keep up with demand – and it is what our customers and partners are asking us for,” said Jonas Muff, CEO and co-founder of Vara. “Today’s clearance is one of several announcements we expect in the coming months.”