Encision files 510(k) application with FDA for AEM simplification product

Encision, a medical device company, has filed a premarket notification under Section 510(k) with the US Food and Drug Administration of its intent to market what has previously been described as an AEM simplification product, and is now called the EndoShield burn protection system.

The EndoShield integrates Encision’s patented AEM technology into a disposable smart cord and eliminates the need for a separate AEM monitor. The EndoShield eliminates the risk of stray energy burns to patients and provides an intuitive, elegant interface for the user.

The device recently received approval from an independent testing agency for IEC 60601-1 electrical safety testing and a 510(k) application was submitted to the FDA last week.

Encision president and CEO Greg Trudel noted the EndoShield is a major evolution of our AEM monitoring system.

"Marketing evaluations of the EndoShield have been conducted in several major U.S. markets, and it has received an overwhelmingly positive response from the nurses and physicians who participated, particularly regarding comments on the simplicity and ease of use of the device. We expect that this product will launch in the Spring of 2014," Trudel added.