08:44 AM EDT, 03/17/2025 (MT Newswires) -- Perimeter Medical Imaging AI ( PYNKF ) on Monday said it has submitted a pre-market Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its next-generation imaging system.

The Perimeter B-Series OCT system combines artificial intelligence technology with optical coherence tomography (OCT), for use during breast-conserving surgeries in the United States.

The FDA PMA submission is the company's first regulatory approval application for its AI-enabled wide-field OCT technology, as well as for a specific indication label, Perimeter said.

"The ultimate product promise of B-Series OCT with ImgAssist AI 2.0 is greater peace of mind. Both for the surgeon who - no matter how skilled - currently faces nearly 1-in-5 odds of needing to perform repeat surgery due to positive margins; and for their patient . . ., " said Perimeter's Chief Executive Officer, Adrian Mendes. "If approved, and based on discussions with physicians, we believe that there is potential for broad adoption of B-Series OCT with ImgAssist AI 2.0 by breast cancer surgeons."