The US Food and Drug Administration (FDA) has granted 510(k) premarket notification approval for Encision’s AEM Endoshield burn protection system.
Encision president and CEO Greg Trudel said that the company is pleased to have achieved this milestone towards the introduction of its EndoShield burn protection system.
"EndoShield integrates our patented AEM technology into a disposable smart cord and eliminates the need for a separate AEM monitor, Trudel added.
"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 pioneered the development and deployment of Active Electrode Monitoring, AEM technology, to eliminate dangerous stray energy burns during minimally invasive procedures.