The single-lead device detects and identifies cardiac rhythm and streams continuous ECG data to remote dashboards.
Summary: Fourth Frontier has received FDA 510(k) clearance for its Frontier X Plus, a single-lead wearable ECG monitor designed for continuous, real-time cardiac monitoring. The chest-worn device wirelessly transmits ECG data to remote dashboards and uses algorithms to detect arrhythmias like bradycardia, tachycardia, and atrial fibrillation. Clinical trials in India and the US demonstrated its signal quality and accuracy on par with traditional 12-lead ECGs, even during intense physical activity. The company plans to launch the device in the US market with partnerships in cardiac rehabilitation centers and diagnostic testing facilities, while also exploring AI integration for early diagnosis.
Key Takeaways:
- FDA Clearance for Frontier X Plus: The Frontier X Plus monitor allows for continuous ECG monitoring and arrhythmia detection during various activities, even under intense exercise.
- High Accuracy Comparable to 12-Lead ECGs: Clinical trials demonstrated that Frontier X Plus matches the accuracy of standard 12-lead ECGs in detecting cardiac arrhythmias.
- US Market Expansion Plans: Fourth Frontier aims to offer the device through partnerships with diagnostic facilities and cardiac rehab centers, with future plans to introduce AI capabilities for early heart condition detection.
Fourth Frontier, a medical technology company based out of New York and Bangalore, has received US Food and Drug Administration 510(k) clearance for its Frontier X Plus, a single-lead, continuous ECG monitor that is worn around the chest.
Frontier X Plus wirelessly relays the user’s ECG instantly to remote dashboards. A range of advanced algorithms identify and classify cardiac rhythm as bradycardia, tachycardia, normal sinus rhythm, or atrial fibrillation.
According to a release from the company, the device demonstrated best-in-class signal quality during a range of motions including during intense exercise. The wearable ECG monitor further demonstrated equivalence in the classification of cardiac arrhythmias when compared with the conventional 12-lead ECG, through clinical trials in India and the US.
“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. The percentage of population that falls in the confluence of these categories is continuously rising. Since the [Frontier X Plus] is able to capture ECGs during all kinds of motion and activity, we think this will be a game-changer and significantly improve the early detection of cardiovascular disease,” says Manav Bhushan, co-founder and CEO of Fourth Frontier, in a release.
With this clearance, the company plans to enter the US market as a prescription-based, class II medical device. Fourth Frontier says it will partner with independent diagnostic testing facilities and cardiac rehabilitation centers to offer at-home remote monitoring services. In the near future, the company has plans to introduce AI algorithms that analyze the ECG for early diagnosis of different kinds of heart conditions.
Photo caption: Frontier X Plus
Photo credit: BusinessWire/Fourth Frontier
