Technology | May 08, 2013

NinePoint Medical Receives Additional FDA 510(k) Clearance for NvisionVLE Imaging System

First volumetric OCT device cleared for endoscopic imaging now also cleared for esophageal imaging indication

Imaging system

NinePoint Medical, Inc., an emerging leader in the development of medical devices for in vivo imaging, announced that it has received an additional 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Nvision VLE Imaging System, expanding the system’s indication to include imaging of esophageal tissue microstructure. In Jan. 2012, the company announced 510(k) clearance from the FDA to market its Nvision VLE 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 Nvision VLE 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 Nvision VLE Imaging System will allow physicians to see more esophageal tissue for biopsy and treatment procedures, providing them with valuable imaging information.”

For more information: www.ninepointmedical.com

 

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