A developer of medical devices for in vivo pathology, NinePoint Medical Inc. of Cambridge, Mass., has initiated a clinical trial to evaluate high-resolution optical imaging of Barrett’s esophagus, a common precursor to esophageal cancer, using its Nvision VLE imaging system. The system received 501(k) clearance from the FDA in January. The single-arm open-label observational trial is designed to evaluate the system’s performance in visualizing subsurface tissue in patients undergoing esophagogastroduodenoscopy for suspected or confirmed Barrett’s esophagus. It is expected to enroll about 100 patients at five leading medical centers worldwide. Commercial launch is planned for 2013.
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