NinePoint Medical Receives FDA 510(k) Clearance
NinePoint Medical, an in vivo pathology device maker and RVL licensee, recently received 510(k) clearance from the U.S. Food and Drug Administration to market its Nvision VLE Imaging System, a next-generation, high resolution optical imaging technology. The Nvision VLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualization. The Nvision VLE Imaging System is designed to enable physicians and pathologists, for the first time, to view high-resolution, volumetric images of organs and tissues in real-time. Clinicians can then analyze and immediately act on these images, thus providing patients with streamlined care and a significantly shortened timeline between detection, diagnosis and treatment of disease. In 2010, Ninepoint Medical exclusively licensed over 188 patents for technologies related to endoscopic optical frequency domain imaging and confocal microscopy products developed in the laboratory of Dr. Gary Tearney and Brett Bouma at the MGH’s Wellman Center for Photomedicine.
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