Perimeter Medical Imaging AI (TSXV:PINK; OTCQX:PYNKF) announced that it has filed a premarket approval (PMA) application for its next-generation B-Series OCT system, which combines proprietary AI technology with optical coherence tomography (OCT), for use during breast-conserving surgeries (BSC) in the U.S.
In November 2024, Perimeter reported positive topline results from the pivotal study designed to support this PMA application, aiming to market B-Series OCT with ImgAssist AI for use during BSC across the U.S.
In a statement, Andrian Mendes, CEO of Perimeter, commented, “The FDA PMA submission is a major milestone—our first regulatory approval application for our AI-enabled wide-field OCT technology, as well as for a specific indication label.”
“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 one-in-five odds of needing to perform repeat surgery due to positive margins; and for their patient, who under the current paradigm, typically has to wait—and worry—for up to seven days for their surgeon to receive a post-operative pathology report, which will determine whether they will have to go through the emotional and physical trauma of a second surgery due to cancer left behind, he added.
Mr. Mendes concluded, “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.”
