NinePoint Medical has received an additional 510(k) clearance from the US Food and Drug Administration (FDA) for its NvisionVLE Imaging System.
The approval will expand the system’s indication to include imaging of esophageal tissue microstructure.
NinePoint Medical Charles Carignan president and chief executive officer said 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.
"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," Carignan added.
"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."
In January 2012, NinePoint had received 510(k) clearance from the agency to commercialise 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.