Encision Receives FDA 510(k) Approval on its AEM EndoShieldT Burn Protection System
Encision Inc., 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 EndoshieldT 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." Encision Inc. designs and markets a portfolio of high performance surgical instrumentation that delivers advances in patient safety with AEM technology, surgical performance, and value to hospitals across a broad range of minimally invasive surgical procedures. Based in Boulder, CO, the company pioneered the development and deployment of Active Electrode Monitoring, AEM technology, to eliminate dangerous stray energy burns during minimally invasive procedures.