NEWS
April 14 , 2008
OPTIM Incorporated Announces 510(k) Clearance of its New ENTity™ NasoView Flexible LED Nasopharyngoscope
FDA Clears New Flexible Nasopharyngoscope for marketing, sales

STURBRIDGE, Mass…OPTIM Incorporated, a premiere manufacturer of flexible endoscopes and related accessories, recently announced 510(k) clearance by the Food and Drug Administration (FDA) for its revolutionary new ENTity™ NasoView; a Flexible LED Illuminated Nasopharyngoscope.

With its self contained, patented LED-Light Engine, ENTity™ stands alone in the world of flexible endoscopy. By freeing the physician from the “tug” of light guides, external light sources and the need for AC wall power, ENTity™ provides unparalleled portability and ease of use. ENTity™, which has been several years in the making, is the brightest and lightest LED-illuminated flexible endoscope available. This is all provided in a uniquely compact, ergonomically elegant package.

Thomas V. Root, President and CEO of the Sturbridge, MA-based Company, says “This clears the way for us to market this groundbreaking technology in the Ear, Nose and Throat (ENT) Market and establishes a platform from which OPTIM can develop new flexible endoscopes that will provide this technology to medical professionals in other disciplines”.

Root says that the portable scope has unparalleled light output, which because it is un-tethered, will enable physicians to act faster, and move more quickly and easily whether it’s in the ER, at the hospital, or in their office. “This truly paves the way for a new era in endoscopy,” he adds.

Douglas Fish, OPTIM’s Manager of Sales & Marketing for ENT Products says: “The FDA’s clearance for the ENTity NasoView has brightened the path for physicians to quickly, simply and easily examine their patients and it positions OPTIM as a pioneer in LED lighting technology for medicine”.

ENTity™ can also be coupled to any standard video camera system and the product’s 3-year warranty on the LED-Light Engine, combined with its other design elements, will also provide lower cost of ownership than conventional scopes.

About ENTity™:

ENTity’s LED Nasopharyngoscope offers an unmatched high intensity LED light source that delivers, complete mobility and maximum flexibility to the user.

Other features include:
• Less than 11 oz total weight
• High intensity LED light source (5500 Kelvin/natural sunlight quality) for exceptional visibility
• Eliminates need for separate external light sources and cables
• Sleek Fully sealed and completely immersible handle
• Variable light intensity; no bulb replacements required
• 3-year warranty on LED Light Engine
• Two-way distal tip articulation, +/- 135 degree
• 3.6 mm insertion shaft diameter - 30 cm insertion shaft working length
• "B" style eyepiece that can use standard camera coupler
• Lithium Ion rechargeable battery
• May be used left or right handed, thumb or finger actuated

About OPTIM Incorporated
OPTIM Incorporated develops, manufactures, markets, services and sells flexible endoscopic products and solutions for commercial, industrial and medical applications. In March 2008 its industrial scope, the FreedomView®, was named “Product of the Year” in Photonics Tech Briefs (PTB) 2007 reader’s choice balloting. The magazine is the only major photonics publication that targets design engineers, and is selectively bound into NASA Tech Briefs, the world’s largest circulation design engineering magazine. For more information on OPTIM Incorporated, go to www.optimnet.com



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