Vara has CE certification for an AI system that reports screening mammograms as normal with no radiologist involved. The Berlin company announced the certificate on September 2. The autonomous triage function is a Class IIb device under the EU Medical Device Regulation. Vara says it is the first breast AI certified to report exams without human review.
The change matters because European screening programs double-read every mammogram. Two radiologists read each exam. Vara's system pulls the exams it rates clearly normal out of that queue. The company's software already handles more than 250,000 screenings a month in Germany, which it puts at over half the national program.
The evidence base is PRAIM, published in Nature Medicine. The study covered 463,094 women at 12 German sites between July 2021 and February 2023. AI-supported reading found 6.7 cancers per 1,000 women against 5.7 for standard double reading, a 17.6 percent increase, with a slightly lower recall rate. Radiologists still read every exam in that study. The autonomous step is new.
The piece worth studying is ATMON, Vara's monitoring system. It sets operating parameters for each site and tracks hardware changes and daily performance signals. When a signal leaves its limits, the site goes back to full radiologist reading. Vara frames this as the human oversight the EU AI Act requires for high-risk systems. The release does not name the notified body and says nothing about a US submission.