NinePoint Medical (Cambridge, MA) just announced FDA approval for its NvisionVLE Imaging System to be marketed for imaging of esophageal tissue microstructure. The technology in the NvisionVLE, based on of Fourier-domain optical coherence tomography (OCT) known as OFDI (optical frequency-domain imaging), originated at Massachusetts General Hospital and delivers a 3D image from one scan of the observed organ in less than 60 seconds. From the announcement:
In January 2012, the company announced 510(k) clearance from the 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 and only volumetric, optical coherence tomography device cleared by the FDA for endoscopic imaging, and now imaging of esophageal tissue microstructure,” said Charles Carignan, M.D., president and chief executive officer of NinePoint Medical. “Expanded FDA 510(k) clearance for imaging of the esophagus represents an important milestone as we progress toward commercializing the NvisionVLE Imaging System this year. We believe that the NvisionVLE Imaging System will allow physicians to see more esophageal tissue for biopsy and treatment procedures, providing them with valuable imaging information.”