Artificial intelligence (AI) has taken a major step towards automated diagnosis in the medical field.

Breast screening company Vara has received CE certification, after which its artificial intelligence-based system will be able to review certain mammograms without the help of a radiologist.

The Berlin-based company announced that its automated triage system has received Class IIb CE certification.

According to the company’s chief executive, Jonas Muff, the approval makes the system the first breast-screening AI to be allowed to independently report clearly normal examinations.

This technology is designed to reduce the workload of radiologists in breast cancer screening, as in the current system, most mammograms are seen twice by radiologists even though they are normal.

Under the new procedure, AI will identify cases that appear normal, while all other examinations will be sent to human radiologists for detailed review.

According to the company, this approach can help experts focus on more complex and risky cases instead of routine low-risk scans, and a monitoring system has also been developed to continuously monitor the AI’s performance.

Vara’s AI system has been used in Germany’s national breast screening program since 2019. The technology was evaluated in a study called PRAIM, which was published in Nature Medicine in 2025. The study evaluated 461,818 women at 12 screening centers.

According to the research, AI-assisted screening detected cancer in every 1,000 women, compared to 5.7 per thousand using traditional double readings, thus recording a 17.6% increase in cancer diagnosis.