Zoll Medical’s latest wearable defibrillator wins FDA nod

The FDA approved Zoll Medical’s wearable defibrillator, which automatically detects and treats ventricular arrhythmias in high-risk hospital patients.

The Hospital Wearable Defibrillator (HWD) is designed to continuously protect patients at risk of ventricular fibrillation or ventricular tachycardia during their hospital stay, Zoll said in a statement.

The HWD automatically detects ventricular fibrillation or tachycardia and immediately delivers a treatment shock, the company said. Speed is crucial in treating patients with these arrhythmias, as any delay in defibrillation raises the risk of complications or death.

“The ability to provide hospitalized patients at risk for malignant ventricular arrhythmias a safe and effective device that enables rapid defibrillation represents a significant improvement in the care of cardiovascular patients,” said David Shavelle, M.D., an associate clinical professor in the division of cardiology at the University of Southern California’s medical school, in the statement.

The device uses the same detection algorithm and defibrillation waveform as Zoll’s defibrillator vest. The FDA cleared the LifeVest defibrillator in 2015 for use in children at risk of sudden cardiac arrest but who are not candidates for an implantable defibrillator.

Also in 2015, Zoll acquired Kyma Medical Technologies for $35 million, picking up the Israeli company’s CE-marked µ-Cor System. It wirelessly monitors fluid in the lungs while also collecting data on heart rate, respiration rate, activity and posture. A consequence of congestive heart failure, fluid buildup in the lungs may be treated with drugs if caught early.