First Volumetric OCT Device Cleared in the US for Endoscopic, Esophageal Imaging

NinePoint Medical, Inc. (Cambridge, MA, USA), a developer of medical devices for in vivo imaging, reported that it has received an additional 510(k) clearance from the US Food and Drug Administration (FDA) for its NvisionVLE imaging system, expanding the system’s indication to include imaging of esophageal tissue microstructure. In January 2012, the company reported 510(k) clearance from the FDA to market its NvisionVLE imaging system for use as an imaging application in the assessment of human tissue microstructure by providing two-dimensional (2D), 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, MD, 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.”

NinePoint is preparing for a commercial launch of the NvisionVLE imaging system in the United States in May 2013. The system is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.

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