3D Mammography Is Coming to European Screening. The Workload Question Comes With It.

Vara received CE mark under EU MDR (Class IIb) for its tomosynthesis AI in June 2026. The approval extends a portfolio that already covers full-field digital mammography as concurrent and independent second reader — and it arrives at a moment when tomosynthesis is moving from the evidence base into procurement specifications across European screening programmes.

Since the publication of PRAIM in Nature Medicine in 2025, Vara has received CE for independent second reading, launched the three-prior model commercially, and extended reach to 10+ European countries through distribution partnerships with DeepC, Sectra Amplifier, Quibim, and Medical Horizons. In Germany, Vara now supports 60% of the organised screening programme — more than 250,000 screenings per month.

Tomosynthesis is the next step in that trajectory. The TOSYMA trial, published in The Lancet Oncology, showed DBT detects invasive cancers at a 48% higher rate than standard mammography. What makes adoption operationally complex is the workload. A two-view tomosynthesis acquisition produces hundreds of reconstructed slices where standard mammography produces four images. In a screening environment already under pressure from radiologist shortages, programmes want the detection benefit but cannot always absorb the reading volume.

Vara’s tomosynthesis model is designed around that constraint. It sits inside existing PACS workflows without adding steps for the radiologist, and programmes already running Vara for standard mammography can extend to tomosynthesis within the same integration. Breast cancer risk prediction follows on the roadmap — moving from case-level reading support to longitudinal monitoring that identifies women at elevated risk before a cancer is detectable.

Vara will be at the Senologiekongress in Munich from 11 until 13 June with a live demonstration. Further information at vara.ai.