FDA 510(k) Approval for Encision’s AEM EndoShield™ Burn Protection System

Encision Inc., a medical device company that exists to prevent dangerous stray electrosurgical burns in minimally invasive surgery, has received FDA 510(k) clearance for its AEM Endoshield™ Burn Protection System.

Background

Encision Inc. tells us it designs and markets a portfolio of high performance surgical instrumentation that delivers advances in patient safety. It says its Active Electrode Monitoring (AEM) technology eliminates dangerous stray energy burns during minimally invasive procedures.

The newly cleared AEM EndoShield utilizes advanced AEM monopolar energy to provide surgeons a what the company claims is a safe energy choice for higher power settings. A convenient add-on that is compatible with widely used electrosurgical generators, in all modes, AEM EndoShield is designed to work with state-of-the-art AEM instruments. The device is an intuitive interface, its plug-and-play design minimizing the need for staff training. Compared with traditional monopolar instrumentation only one additional connection is required as shown.

Encision will no doubt be pleased it’s in the headlines for the right reasons, as the company has also been in the news as a result of a case of mistaken identity. Somehow, the company has been wrongly fingered for its involvement in the surgical mesh troubles that are currently filling the courtrooms. Happily for Encision it neither manufactures nor distributes a surgical mesh, so it’ll be expecting that particular storm to pass pretty quickly.

Company comments

“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.”

Source: Encision, Inc., PR Newswire

 

 

 

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