Vara, an AI company based in Berlin, has become the first in the world to receive regulatory approval for a breast triage tool that allows for certain mammograms to be classified as normal without a radiologist review. The firm announced it achieved CE Certification under the EU's Medical Device Regulation for its autonomous triage product, which remains designed for organized population screening amidst a declining radiologist workforce. This new AI system is part of Atmon, which continuously monitors operational systems in real-time and ensures safety compliance. It has been shown to potentially increase breast cancer detection rates by nearly 20% in a large study involving 462,000 women in Germany. While Vara's technology has seen widespread use in Germany, it is currently not available in the U.S. The company has also attracted $34 million in funding, including a recent $9 million round aimed at expanding into India.
Thu, 03 Sep 2026 06:07:49 GMT | Radiology Business