April 22, 2008, Sturbridge, MA--OPTIM Inc., a manufacturer of flexible endoscopes and related accessories, has gained 510(k) FDA clearance for its new ENTity NasoView, a flexible LED-illuminated nasopharyngoscope.
"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," says Thomas Root, president and CEO of OPTIM.
According to the company, with its self-contained, patented LED light engine, ENTity is unique 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 portability and ease of use. ENTity, which has been several years in the making, is the brightest and lightest LED-illuminated flexible endoscope (5500 Kv) available. 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.