Kirkland, Wash.-based Kestra Medical Technologies, Inc., announces that it has received U.S. FDA Premarket Approval for the ASSURE wearable cardioverter defibrillator (WCD) system, which monitors and treats patients at risk of sudden cardiac death.
The system includes a wearable device with integrated sensors, a cardiac rhythm monitor, and miniaturized automated external defibrillator. Moreover, the ASSURE WCD can analyze a patient’s heart rhythm, independently identify a dangerous arrhythmia, make an autonomous treatment decision, and safely deliver defibrillation therapy—a shock to the patient’s heart—to restore a normal heart rhythm.
Company officials add that the system is compatible with Kestra’s cloud-based digital health platform, which enables communication with both patients and physicians.
“We know WCDs save lives when they are worn, but one of the biggest challenges is getting patients to wear them,” says Brian Webster, CEO. “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.”
The company expects the ASSURE system to become available in select markets in the fall of 2021.