Encision Receives 510(k) Approval for AEM Endoshield Burn Protection System

The FDA has cleared Encision’s AEM Endoshield electrosurgical burn protection system for marketing in the U.S., the Boulder, Colo., devicemaker announced Friday.

The device — designed to prevent burns in minimally invasive surgery — merges Encision’s Active Electrode Monitoring technology with a disposable smart cord, eliminating the need for a separate AEM monitor. “Encision’s AEM burn protection system eliminates the chance of stray energy burns to patients during laparoscopy, by electrically shielding and monitoring the AEM instrument inside the patient’s body,” the company’s website explains.

According to the company, AEM monitoring ensures that the integrity of the laparoscopic instrument is not compromised during surgery by overheating, thereby preventing the risk of a burn injury to the patient.

Encision President and CEO Greg Trudel said customer feedback has been very positive, emphasizing the device’s ease of use, ability to increase patient safety and cost-effectiveness. — Kellen Owings

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