“The ISO certification and CE mark approval are important milestones for NinePoint Medical and, along with our recently announced 510(k) clearance from the FDA, strongly position the NvisionVLE Imaging System for a commercial launch in 2013,”
NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo pathology, has announced that it has gained CE mark approval for the NvisionVLE™ Imaging System. The CE Mark is for the company’s “optical endomicroscopy imaging devices for diagnosis of mucosa and submucosa diseases.” The company has also received ISO 13485:2003 certification, an international standard governing the requirements of a quality management system for medical devices and related services, for the company’s Cambridge facility.
NinePoint Medical recently initiated a clinical trial to evaluate high-resolution optical imaging of Barrett’s Oesophagus using the NvisionVLE Imaging System. Barrett’s Oesophagus, as discussed with surprising frequency on our pages, is one of the most common precursors to Oesophageal adenocarcinoma, the fastest growing cancer in the Western world.
With the CE Mark, the company will now add two sites in Europe to the clinical trial. In addition, in January 2012 the company announced FDA 510(k) clearance to market its NvisionVLE Imaging System for use as an imaging tool in the evaluation of human tissue microstructure by providing two-dimensional, cross sectional, real-time depth visualisation.
The NvisionVLE Imaging System is the first volumetric, optical coherence tomography (OCT) device cleared by the FDA for endoscopic imaging that generates cross sectional and longitudinal images simultaneously, in real time.
“The ISO certification and CE mark approval are important milestones for NinePoint Medical and, along with our recently announced 510(k) clearance from the FDA, strongly position the NvisionVLE Imaging System for a commercial launch in 2013,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical.
Source: NinePoint Medical, Inc.