Kestra Medical Technologies announced today that it received FDA approval for its Assure wearable cardioverter defibrillator (WCD) system.
Kirkland, Wash.-based Kestra designed its Assure WCD system as a modern, comfortable wearable device with integrated sensors, a cardiac rhythm monitor and a miniaturized automated external defibrillator, according to a news release.
The system, designed to protect patients at risk of sudden cardiac death (SCD), can analyze a patient’s heart rhythm, independently identify a dangerous arrhythmia, make an autonomous treatment decision and safely deliver defibrillation therapy to restore a normal heart rhythm.
Additionally, the system includes compatibility with Kestra’s cloud-based digital health platform designed for enabling communication with both patients and physicians. Kestra expects Assure to become available in select markets in the fall of this year.
“We know WCDs save lives when they are worn, but one of the biggest challenges is getting patients to wear them,” Kestra CEO Brian Webster said in the release. “Kestra designed our first product, the Assure system, with the latest available technology, to provide an easier to use and more wearable solution for patients that also delivers high-fidelity data notifications to physicians to improve patient care.”