German Berlin-based AI healthcare company Vara announced that its breast cancer screening AI system has received CE certification of Class IIb under the EU Medical Device Regulation (MDR), becoming the world's first AI system to be regulated and approved for autonomous triage in breast cancer screening.
This certification allows the AI to directly exclude clearly normal mammograms from radiologists' review, while other cases still require at least one radiologist to verify. This model is only applicable to organized population screening and not for symptomatic patients or diagnostic examinations.
Vara stated that European screening programs typically involve two readings per mammogram, with approximately 97% of images being normal. Meanwhile, the number of radiologists continues to decline, while the screening population keeps growing. The key to this certification is not solely relying on the AI model, but rather the accompanying ATMON autonomous triage monitoring system, which continuously monitors equipment, system operation status, cancer detection rate, and recall rate. If any indicators exceed predefined thresholds, it will automatically switch back to full radiologist review.
The certification was mainly based on the PRAIM study. This study was conducted between July 2021 and February 2023 in 12 locations in Germany, covering 463,094 women. The cancer detection rate in the AI-assisted group was 6.7 per thousand, compared to 5.7 per thousand in the control group, representing a relative increase of 17.6%. However, this study tested AI-assisted double reading and did not directly validate the autonomous triage model approved this time.
