AI Can Now Clear Some Mammograms Without a Radiologist’s Review

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AI just got the green light to make a breast-screening decision on its own. Image: Vara

Vara has received CE certification allowing its AI to clear some mammograms as normal without radiologist review, marking a step toward autonomous medical AI.

Sep 4, 2026

AI has taken a significant step beyond assisting radiologists: a breast-screening system has been cleared to report some mammograms as normal without a human reviewing every case.

Berlin-based Vara announced on Wednesday, Sep 2, that it had received Class IIb CE certification for its autonomous triage system. According to a Substack post by the company’s CEO, Jonas Muff, the clearance makes Vara the first breast-screening AI to be cleared to independently report examinations as clearly normal.

The move addresses a specific problem in organized breast-cancer screening: programs commonly rely on radiologists to read mammograms twice, even though most screening examinations are normal. Vara’s approach is to let...

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