Fourth Frontier, a medical technology company with operations in New York and Bangalore, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its innovative Frontier X Plus device.
This wearable ECG monitor is designed to be worn around the chest and provides continuous heart monitoring by wirelessly transmitting real-time ECG data to remote dashboards.
The Frontier X Plus utilizes advanced algorithms to detect and classify various cardiac rhythms, including Bradycardia, Tachycardia, Normal Sinus Rhythm, and Atrial Fibrillation. Clinical trials conducted in India and the U.S. have demonstrated that the device offers signal quality comparable to traditional 12-lead ECGs, even during intense physical activity.
According to the Centers for Disease Control and Prevention (CDC), cardiovascular disease (CVD) claims a life every 33 seconds in the U.S., accounting for one in five deaths. The American Heart Association estimates that between three to six million Americans have experienced Atrial Fibrillation, a figure expected to rise to 16 million by 2050. This condition is increasingly recognized as a global epidemic, affecting individuals of all ages and contributing significantly to premature mortality.
Manav Bhushan, co-founder and CEO of Fourth Frontier, emphasized the growing prevalence of cardiac arrhythmias among active individuals with health risks. He stated, “The percentage of the population that falls into these categories is continuously rising. The FX+ can capture ECGs during all kinds of motion and activity, which we believe will significantly enhance early detection of cardiovascular disease.”
With FDA clearance secured, Fourth Frontier plans to launch the Frontier X Plus as a prescription-based Class II medical device. The company will collaborate with Independent Diagnostic Testing Facilities (IDTFs) and cardiac rehabilitation centers to provide remote monitoring services for patients at home.
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