NinePoint Medical (Cambridge, MA) received European clearance for the NvisionVLE Imaging System, a device for endomicroscopic imaging for diagnosis of mucosa and submucosa diseases. The technology behind the NvisionVLE, a variation of Fourier-domain optical coherence tomography (OCT) known as OFDI (optical frequency-domain imaging), was developed at Massachusetts General Hospital and provides a 3D image from one scan of the observed organ in less than 60 seconds.
The company expects the device to be initially used in diagnosing Barrett’s esophagus and esophageal dysplasia.
More from the announcement:
NinePoint Medical recently initiated a clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus using the NvisionVLE Imaging System. Barrett’s esophagus is one of the most common precursors to esophageal 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 510(k) clearance from the U.S. Food and Drug Administration (FDA) 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 visualization. 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.