Mr. Jeremy Sobotta reports
PERIMETER MEDICAL IMAGING AI ANNOUNCES U.S. FDA 510(K) CLEARANCE FOR OCT IMAGING SYSTEM
Perimeter Medical Imaging AI Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Perimeter's optical coherence tomography (OCT) imaging system (version 2.1), which is designed to examine tissue microstructures during surgical procedures by providing cross-sectional, real-time margin visualization.
Jeremy Sobotta, Perimeter's chief executive officer, stated: "This is an exciting and important milestone for Perimeter that enables us to bring our commercial-ready OCT imaging system to the U.S. market. Throughout clinical development, we listened to our users; and this clearance covers a product that delivers on their feedback, allowing for a streamlined integration into current intraoperative workflows. We are thrilled to bring physicians our platform providing real-time margin visualization to assist their decision making, and our goal is to help them create better long-term outcomes for patients while lowering costs to the health care system."
Mr. Sobotta added: "Our Perimeter OCT imaging system is the foundational building block that allows us to continue developing next-gen improvements, such as the artificial intelligence tools currently in development under our Atlas AI project."
Perimeter's OCT imaging system is indicated for use as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization with image review manipulation software for identifying and annotating regions of interest.
About Perimeter Medical Imaging AI Inc.
Perimeter Medical Imaging AI is a Toronto-based company with U.S. headquarters in Dallas, Tex., that is developing, with plans to commercialize, advanced imaging tools that allow surgeons, radiologists and pathologists to visualize microscopic tissue structures during a clinical procedure. Perimeter's OCT imaging platform is a point-of-care imaging system that provides clinicians with real-time, ultrahigh-resolution, subsurface image volumes of the margin (one millimetre to two millimetres below the surface) of an excised tissue specimen. The ability to visualize microscopic tissue structures during a clinical procedure in addition to standard-of-care tissue assessment for decision making during the procedure has the potential to result in better long-term outcomes for patients and lower costs to the health care system. Perimeter's OCT imaging platform is cleared by the FDA as an imaging tool in the evaluation of excised human tissue microstructure by providing two-dimensional, cross-sectional, real-time depth visualization, with image review manipulation software for identifying and annotating regions of interest. In addition, Perimeter is developing advanced artificial intelligence/machine learning image assessment tools intended to increase the efficiency of review.
Perimeter's ticker symbol, PINK, is a reference to the pink ribbons used during Breast Cancer Awareness Month by the Canadian Cancer Society and the American Cancer Society, driving home the company's dedication to helping surgeons, radiologists and pathologists use Perimeter's imaging technology and AI (artificial intelligence) in the fight against breast cancer, which is estimated to account for 30 per cent of all female cancer diagnoses this year.
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