News | September 24, 2007

Vision-Sciences Receives FDA Clearance for Video-Based Advanced Endoscopy Lines

September 25, 2007 — Vision-Sciences Inc. recently announced it received 510(k) clearance from the FDA to market the new line of advanced digital, video-based flexible endoscopes, which come with an integrated "built-in" light source, eliminating the need for a separate camera head, light cable and optical coupler.

The ENT and TNE scopes are the first two in the series of uniquely advanced digital endoscopy platforms to be introduced by Vision-Sciences. These lightweight videoscopes facilitate diagnostic and therapeutic procedures with an insertion tube that contains a high resolution, tiny CCD (charge coupled device) camera at the tip of the insertion tube, offering a sharp, high definition, vibrant full screen image, according to the manufacturer.

The ENT-5000 flexible video laryngoscope is inserted in the nose down to the throat, reportedly providing precise, vivid images of the internal structures of the nasal cavity, vocal folds, larynx and other areas of the throat. The TNE-5000 flexible video transnasal esophagoscope allows visualization further down the esophagus and all the way down to the stomach. These are used to examine patients suffering from various disorders, ranging from difficulty in swallowing or breathing, sleep apnea, asthma, chronic cough, gastroesophageal reflux disease Barrett's disease and symptoms of cancer.

Vision-Sciences scopes are used in conjunction with the company's patented, disposable, sterile Slide-On EndoSheath technology that covers the entire scope.

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