Nathaniel Group medical illuminators for microendoscopy receive regulatory approvals

Hyperion 200L and Hyperion 200LV medical illumination systems from Nathaniel Group (Vergennes, VT), which allow access to areas of the anatomy previously inaccessible with conventional minimally invasive endoscopes, have been certified for use in the United States, Canada, and the European Union (EU). Both light sources offer full endoscopic illumination from a single fiber as small as 170 or 250 µm.

Related: Microendoscopy takes a practical turn

The two illuminators were evaluated by independent companies to verify they met stringent standards for electromagnetic compliance, laser safety, usability, risk management, and other safety requirements. The certifications will help medical device manufacturers bring new products to market faster and at a lower regulatory cost, according to Joel Melnick, CEO of Nathaniel Group.

Since achieving the CE mark, in addition to U.S. and Canada certification, several of the illuminators have been purchased for evaluation and incorporated into human use applications by medical device manufacturers throughout the U.S. and EU.

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