NinePoint Medical, a developer of real-time in vivo pathology devices, has obtained CE mark approval for its NvisionVLE Imaging system.
The NvisionVLE Imaging system facilitates physicians and pathologists to view real-time volumetric images of organs and mucosa and submucosa tissues up to 3mm deep.
The company recently started a clinical trial to assess optical imaging of Barrett’s esophagus using the NvisionVLE Imaging system.
With the CE mark, the company will now add two sites in Europe to the clinical trial.
The company also received ISO 13485:2003 certification for its Cambridge, Massachusetts, US, facility.
NinePoint Medical president and chief executive officer Charles Carignan said 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."