Vara has announced that it has received a new CE certificate for its new breast-imaging AI. According to the company, it is the only one of its kind on the market allowed to operate as an independent second reader for both screening and diagnostic use. This marks the company’s entry into the European market.
The company says the milestone comes at a critical moment, with national screening programs in Europe facing mounting radiologist shortages, as well as aging populations and expanded age ranges that demand even more expert time. Vara’s CE mark affirms the safety and clinical evidence for AI as a second reader.
The CE-marked product is now available in Europe, as an independent second read or decision support system including analysis of mammograms from prior screening rounds. Providers can integrate Vara directly in their PACS viewer or via the Vara platform, the latter of which currently serves 40% of the German national screening program.
“Our ambition has always been to pioneer data-driven AI at a nationwide scale,” said Stefan Bunk, Co-Founder and CTO of Vara. “The industry has long moved beyond retrospective evidence. Now, by pairing population-wide, real-world results with automatic real-time monitoring, we’re offering a credible, scalable path for AI as an independent reader – and we’re grateful the regulator acknowledged this approach.”
