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. FDA for its Optical Coherence Tomography (OCT) Imaging System (v2.1). This system is designed to provide cross-sectional, real-time visualization of tissue microstructures during surgical procedures, addressing significant unmet medical needs. CEO Jeremy Sobotta highlighted the system's potential to improve patient outcomes and streamline surgical workflows. The clearance marks a pivotal step for Perimeter in bringing its 'commercial ready' product to the U.S. market, alongside future enhancements under the ATLAS AI project.
- Received 510(k) clearance from the U.S. FDA for OCT Imaging System (v2.1).
- Enables commercialization of advanced imaging tools in the U.S. market.
- Designed for real-time margin visualization improving surgical decision-making.
- Potential to enhance patient outcomes while reducing healthcare costs.
- None.
Perimeter Medical Imaging AI, Inc. (TSX-V:PINK)(OTC:PYNKF) (FSE:4PC) (“Perimeter” or the “Company”), a medical technology company driven to transform cancer surgery with ultra-high-resolution, real-time, advanced imaging tools to address areas of high unmet medical need, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Perimeter’s Optical Coherence Tomography (OCT) Imaging System (v2.1), which is designed to examine tissue microstructures during surgical procedures by providing cross-sectional, real-time margin visualization.
Perimeter Medical Imaging AI has received 510(k) clearance from the U.S. FDA for Perimeter's Optical Coherence Tomography (OCT) Imaging System (v2.1) (Photo: Business Wire)
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 healthcare 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. For more information, please visit: www.perimetermed.com
About Perimeter Medical Imaging AI, Inc.
Perimeter Medical Imaging AI (TSX-V:PINK)(OTC:PYNKF)(FSE:4PC) is a Toronto-based company with U.S. headquarters in Dallas, Texas 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, ultra-high-resolution, sub-surface image volumes of the margin (1-2 mm 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 d
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