FDA Premarket Approval Granted for Wearable Cardioverter Defibrillator

Kestra Medical Technologies Inc. has received U.S. Food and Drug Administration (FDA) premarket approval for the ASSURE Wearable Cardioverter Defibrillator (WCD) system.
 
The ASSURE WCD system represents the next generation of monitoring and therapy to protect patients at risk of sudden cardiac death (SCD). The system includes a modern, comfortable wearable device with integrated sensors, a cardiac rhythm monitor and miniaturized automated external defibrillator. 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. The system is compatible with the company’s cloud based digital health platform that 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,” said 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.”
 
Kestra Medical Technologies Inc. is a privately held wearable medical device and digital healthcare company that protects cardiac patients with diagnostic monitoring and therapeutic technologies that are intuitive, intelligent, and mobile. Kestra was founded in 2014 by leaders from the external (AED) and internal (ICD) defibrillation industries. Based in Kirkland, Wash., Kestra’s financial sponsor is Bain Capital.