NinePoint Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Nvision VLE imaging system, a next-generation, high-resolution optical imaging technology.
The Nvision VLE imaging system, the first volumetric optical coherence tomography (OCT) device cleared by the FDA, is intended for use as an imaging tool in the examination of human tissue microstructure by providing 2D, cross-sectional, real-time depth visualisation.
The VLE imaging system uses a circumferential scanning technique and an automatic pullback to produce cross sectional and longitudinal images simultaneously in real-time, enabling physicians and pathologists to view high-resolution, volumetric images of organs and tissues.
The imaging system uses a high-resolution display and proprietary software to generate an image that can be reviewed by a clinician to detect areas of suspicion, providing patients with streamlined care and a considerably shortened timeline between detection, diagnosis and treatment of disease.
NinePoint Medical’s imaging system can image beneath the mucosal surface at less than 10µg resolution up to a tissue depth of 3mm. It provides a full-field, circumferential view, compared with confocal microscopy, which only offers a 0.5×0.5mm segment of tissue.
NinePoint Medical president and CEO Charles Carignan said the company’s aim is to provide physicians with higher-resolution cross-sectional and longitudinal images of diseased tissue in the epithelium of various organs.
”We will be conducting clinical trials of the Nvision VLE Imaging System in 2012 and will be scaling up our manufacturing capabilities to support a commercial launch in 2013,” Carignan added.
”We believe our technology can improve patient outcomes, shorten the timeframes associated with diagnostic and treatment procedures and significantly reduce health care system costs."
NinePoint Medical Regulatory affairs acting vice president Cindy Domecus said they hope the high-resolution images will provide additional, important detail to clinicians who are diagnosing disease that is often not visible on the surface.
”We look forward to developing the Nvision VLE Imaging System into a tool to improve patient care across a broad spectrum of disease states,” Domecus said.