Perimeter Medical files PMA application for Perimeter B-Series OCT system
Perimeter Medical Imaging AI announced the submission of a Premarket Approval application to the U.S. Food and Drug Administration for the Company's next-generation Perimeter B-Series OCT system, which combines proprietary artificial intelligence technology with optical coherence tomography, for use during breast-conserving surgeries in the United States. In November 2024, Perimeter reported topline results from the pivotal study designed to support the Company's FDA PMA for B-Series OCT with ImgAssist AI 2.0 for use during breast-conserving surgeries in the United States. The pivotal trial met its primary endpoint, achieving a statistically significant reduction in patients with residual cancer during surgery. These results demonstrated super-superiority of the Perimeter B-Series OCT with ImgAssist AI 2.0 system's ability to aid surgeons in achieving clear surgical margins during surgery, potentially lowering the need for reoperation.
