Perimeter Medical Imaging AI Gains FDA Approval for AI Breast Surgery Device

March 04, 2026
Perimeter Medical Imaging AI has received FDA premarket approval for Claire, the first AI-enabled imaging device approved in the U.S. for intraoperative breast cancer margin assessment. The device uses optical coherence tomography and AI to help surgeons detect hidden cancer tissue during breast-conserving surgery.

Perimeter Medical Imaging AI has received FDA premarket approval for Claire, the first AI-enabled imaging device cleared in the U.S. for intraoperative breast cancer margin assessment, announced in a press release.

Claire combines optical coherence tomography with artificial intelligence to help surgeons identify hard-to-see cancer tissue during breast-conserving surgery. Clinical trials showed the device achieved an 88.1% margin accuracy and significantly reduced cases of residual cancer compared to standard surgical practices.

The company plans a nationwide rollout of the technology to support improved surgical outcomes and reduce the need for repeat procedures.

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