The US Food and Drug Administration (FDA) has granted 510(k) clearance for NinePoint Medical's Nvision VLE imaging system, a next-generation, high-resolution optical imaging technology.
The Nvision VLE imaging system uses a circumferential scanning technique and an automatic pullback to generate cross sectional and longitudinal images of organs and tissues simultaneously in real-time.
The VLE imaging system, an optical coherence tomography (OCT) device, utilises a high-resolution display and proprietary software to produce an image that can be reviewed by a clinician to identify areas of suspicion.
NinePoint Medical president and CEO Charles Carignan said they will be conducting clinical trials of the Nvision VLE Imaging System in 2012 and will be scaling up the manufacturing capabilities to support a commercial launch in 2013.
”We believe our technology can improve patient outcomes, shorten the timeframes associated with diagnostic and treatment procedures and significantly reduce health care system costs." Carignan added.