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

 

Related Content

Body Vision Medical Announces Release of LungVision
Technology | Lung Cancer | October 05, 2018
Body Vision Medical, a medical device company specializing in lung cancer diagnostics, announced the launch of its...
American Society for Gastrointestinal Endoscopy and Touch Surgery Pilot Video-Based Endoscopic Simulations
News | Endoscopes | June 11, 2018
During the 2018 Digestive Disease Week (DDW) conference June 2-5 in Washington, D.C., the American Society for...
Olympus and Hitachi Healthcare Americas Introduce Arietta 850
News | Ultrasound Imaging | June 04, 2018
Olympus, a global technology leader in designing and delivering innovative solutions for medical and surgical procedu
Body Vision Medical Receives FDA Clearance for LungVision Tool
Technology | Lung Cancer | May 09, 2018
Body Vision Medical received clearance from the U.S. Food and Drug Administration (FDA) to market their LungVision Tool...
El Camino Hospital Performs First U.S. Robotic Lung Cancer Bronchoscopy
News | Oncology Diagnostics | April 25, 2018
The interventional pulmonology team at the Taft Center for Clinical Research at El Camino Hospital in Mountain View,...
News | Endoscopes | April 02, 2018
Results from a recent prospective trial found the Wide Area Transepithelial Sampling with 3D Tissue Analysis (WATS3D)...
Auris Health Unveils FDA-Cleared Monarch Platform for Robotic Bronchoscopy
Technology | Endoscopes | March 26, 2018
March 26, 2018 — Auris Health Inc. announced U.S.
FDA, CDC and ASM Release New Duodenoscope Surveillance and Culturing Protocols
News | Endoscopes | February 26, 2018
The U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and American Society for...
Dilon Technologies Inc. Launches New CoPilot VL+ Video Laryngoscope
Technology | Endoscopes | February 07, 2018
February 7, 2018 — Dilon Technologies Inc.
CapsoVision Inc. Introduces CapsoCloud for CapsoCam Plus Endoscopy System
Technology | Endoscopes | September 14, 2017
CapsoVision Inc. recently announced the full U.S. launch of CapsoCloud, an exam management system that allows...