FDA grants Encision 510(k) approval for AEM Endoshield Burn Protection System

Encision Inc. (ECIA:PK), a medical device company owning patented surgical technology that prevents dangerous stray electrosurgical burns in minimally invasive surgery, today announced that it has received FDA 510(k) premarket notification approval for its AEM Endoshield™ Burn Protection System ("EndoShield").

"We are pleased to have achieved this milestone towards the introduction of our EndoShield burn protection system," said Greg Trudel, Encision's President & CEO. "EndoShield integrates our patented AEM® technology into a disposable smart cord and eliminates the need for a separate AEM monitor. Feedback from the marketplace has been very positive. Our customers appreciate the advancement of the technology, the increase in ease of use, and the freedom from the constraint of capital expense. We look forward to launching our new device and to increasing the proliferation of advanced AEM monopolar energy and patient safety."