The US Food and Drug Administration (FDA) has granted premarket approval to Kestra Medical Technologies’ ASSURE wearable cardioverter defibrillator (WCD) system.
The ASSURE WCD system comprises a wearable device with incorporated sensors, a cardiac rhythm monitor and a miniaturised automated external defibrillator.
It is intended for monitoring and treatment in patients who are the risk of sudden cardiac death.
The system can evaluate the heart rhythm of the patient and detect fatal arrhythmia. It can independently take a therapy decision and safely offer defibrillation to restore normal cardiac rhythm.
Defibrillation is a treatment that provides a shock to the heart of the patient.
Furthermore, the system can be integrated with Kestra’s Cloud-based digital health platform that facilitates communication with patients and doctors.
Kestra Medical Technologies CEO Brian Webster said: “We know WCDs save lives when they are worn, but one of the biggest challenges is getting patients to wear them.
“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 plans to launch the ASSURE system in some markets in the coming months.
In another development, the FDA has cleared Abbott’s new optical coherence tomography (OCT) imaging platform driven by its Ultreon software.
The imaging software leverages OCT and artificial intelligence to offer doctors an improved and complete view of coronary blood flow and blockages. This aids physicians to adopt decisions on the most suitable treatment pathway.
In addition, Ultreon can be connected to Abbott’s Dragonfly OpStar imaging catheter and PressureWire X guidewire to offer doctors various tools to evaluate coronary blood flow and blockages, as well as enhance therapy planning.
The latest development comes after the FDA approved the Abbott FreeStyle Libre 2 iOS application for checking glucose levels to manage diabetes.