(SeaPRwire) –
By: Oliver Hawthorne
European breast cancer screening programs are stretched dangerously thin right now. Radiologist shortages keep growing as national guidelines push for faster 3D tomosynthesis adoption. Most AI vendors cannot prove they can operate at national scale to win large public tenders. Few also hold the regulatory clearances needed to act as independent screening readers.
On June 10, 2026, Berlin-based Vara received CE class 2b marking under EU MDR for its tomosynthesis AI solution. The company already powers over half of Germany’s organized breast cancer screening program. It processes more than 250,000 screenings per month. Its PRAIM study, published in Nature Medicine in 2025, is the largest prospective AI screening study to date. The study validates its ability to operate at national scale. In the 12 months after PRAIM’s publication, Vara expanded to 10+ European countries. It signed distribution partnerships with DeepC, Sectra Amplifier, Quibim and Medical Horizons. It also secured CE approval for its independent second reader product in the past year. It commercially launched its 3-prior AI model in the same window. More announcements, including a breast cancer risk prediction tool, are expected soon per CEO Jonas Muff.
Vara’s unmatched combination of proven scale, full regulatory clearance and existing distribution network makes it the default pick for all upcoming European 3D screening tenders. Smaller competing AI vendors without comparable track records will be locked out of the public European breast cancer screening market entirely within two years.
Author bio: Oliver Hawthorne, principal correspondent covering medical AI and healthcare tech for a leading international technology review.