News | January 07, 2008

FDA Clears Video-Based Cystoscopy Line

January 8, 2008 - Vision-Sciences Inc. received FDA 510(k) clearance to market its new advanced digital, video-based flexible Cystoscope, used in conjunction with an integrated "built-in" light source, eliminating the need for a separate camera head, light guide cable and optical coupler.

The Cystoscope is the third in the series of advanced digital endoscopy platforms introduced by Vision-Sciences. The lightweight videoscopes facilitate diagnostic and therapeutic procedures with the introduction a diameter videoscope insertion tube containing a high-resolution, miniature CCD (charge coupled device) camera at the tip of the insertion tube, offering a sharp, high definition full screen image.

The Vision-Science' scopes are used in combination with the company's patented, disposable, sterile Slide-On EndoSheath technology that covers the entire scope. The proprietary EndoSheath technology not only isolates the endoscope from the patient, but contains a disposable operative channel. This prevents instrumentation and patient tissue biopsies from coming in contact with the reusable scope, unlike when passed through the built-in channel of conventional scopes from other manufacturers. The EndoSheath Technology eliminates the need for elaborate high-level disinfection between procedures, leading to rapid equipment turnover, limiting capital investment for additional scope inventory, reducing staff exposure to toxic chemicals, and dramatically lowering repair and maintenance costs.

For more information: www.visionsciences.com

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