Fourth Frontier, a medical technology company with locations in New York and Bangalore, has announced that its Frontier X Plus device has received 510(k) clearance from the U.S. FDA. The Frontier X Plus is a single-lead, continuous ECG monitor designed to be worn around the chest, providing real-time wireless transmission of the user's ECG data to remote dashboards.
The device employs advanced algorithms to identify and classify cardiac rhythms, specifically Bradycardia, Tachycardia, Normal Sinus Rhythm, and Atrial Fibrillation. These classifications are crucial for early detection and management of cardiovascular conditions.
Clinical Performance
The Frontier X Plus has demonstrated high signal quality during various activities, including intense exercise. Clinical trials conducted in both India and the US have shown that the device's classification of cardiac arrhythmias is equivalent to that of a conventional 12-lead ECG.
The Growing Burden of Cardiovascular Disease
Cardiovascular diseases (CVDs) are a leading cause of mortality in the United States, with one person dying every 33 seconds from CVD, according to the Center for Disease Control. CVDs account for one in every five deaths in the US. Atrial Fibrillation, a common arrhythmia, affects between three to six million Americans, a number projected to rise to 16 million by 2050, according to the American Heart Association.
Manav Bhushan, co-founder and CEO of Fourth Frontier, noted the increasing incidence of cardiac arrhythmias in individuals of all ages, particularly those who are active and have cardiac risk factors. "We have seen cardiac arrhythmias develop in individuals of all ages, and the incidence is significantly higher for individuals who are both active and have cardiac health risk factors," said Bhushan. "Since the FX+ is able to capture ECGs during all kinds of motion and activity, we think this will be a game changer and significantly improve on the early detection of cardiovascular disease."
Market Entry Strategy
With this FDA clearance, Fourth Frontier plans to enter the US market as a prescription-based, class II medical device. The company intends to partner with Independent Diagnostic Testing Facilities (IDTFs) and cardiac rehabilitation centers to provide at-home remote monitoring services.
