NinePoint Medical won an expanded FDA nod for its NvisionLVE system, which can now be used for esophageal imaging procedures.
The Cambridge, Mass.-based medical device company won FDA clearance in January 2012 for an indication to evaluate human 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," said CEO Charles Carignan in prepared remarks. "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."
Last year, NinePoint won CE Mark approval in the European Union for the NvisionVLE device, for diagnosis of mucosal and submucosal disease.
