Optical coherence tomography (OCT) developer NinePoint Medical has received European CE Mark approval for its NvisionVLE imaging system, the company said.
NvisionVLE is a volumetric, OCT device for endoscopic imaging that generates cross-sectional and longitudinal images simultaneously, in real time.
The CE Mark is for the company's optical endomicroscopy imaging devices for diagnosis of mucosa and submucosa diseases, according to NinePoint. The firm has also received ISO certification for its Cambridge facility.
NinePoint received 510(k) clearance for Nvision VLE from the U.S. Food and Drug Administration in January for use as an imaging tool in the evaluation of human tissue microstructure by providing 2D, cross-sectional, real-time depth visualization. The company expects to launch the unit commercially in 2013.
