AI-Powered Wearable ECG Monitor to Improve Early Detection of Cardiovascular Disease

By HospiMedica International staff writers
Posted on 24 Dec 2024

Image: The Frontier X Plus ECG wearable has received U.S. FDA 510(k) clearance (Photo courtesy of Fourth Frontier)

Atrial fibrillation is recognized as a global health epidemic and serves as a key indicator of increased morbidity and mortality across all age groups. The incidence and prevalence of cardiovascular disease (CVD) are rising, particularly among younger individuals, and it remains one of the leading causes of premature death. Now, an innovative single-lead, continuous ECG monitor, worn around the chest, offers automated detection of atrial fibrillation and other arrhythmias.

The Frontier X Plus ECG wearable, developed by Fourth Frontier (New York, NY, USA), utilizes advanced algorithms to detect and classify cardiac rhythms such as bradycardia, tachycardia, normal sinus rhythm, and atrial fibrillation. The cutting-edge device is wireless and adhesive-free, enabling patients to begin monitoring their heart rhythms in less than one minute. The wearable instantly transmits ECG data to remote dashboards, allowing clinicians to monitor multiple patients simultaneously and verify the quality of the signals remotely. Hospitals using Fourth Frontier tools can manage patient accounts, receive activity notifications, and download raw ECG data, while summary trend lines of key metrics assist in early decision-making and refine clinical decisions.

Clinical trials have shown that the wearable ECG monitor performs similarly to the conventional 12-lead ECG in classifying cardiac arrhythmias. The study involved 832 patients and compared the Frontier X Plus device with the traditional FDA-cleared 12-lead ECG in both clinical and real-world settings, including individuals with and without atrial fibrillation. The Frontier X Plus demonstrated a sensitivity of 98.10% and specificity of 97.88% for detecting atrial fibrillation, when compared to the 12-lead ECG, with the results confirmed by three independent cardiologists. The Frontier X Plus has received 510(k) clearance from the U.S. FDA, enabling the company to enter the U.S. market as a prescription-based, class II medical device. In the future, Fourth Frontier plans to integrate AI algorithms to analyze ECG data for the early detection of various heart conditions, potentially transforming the device into a breakthrough tool for everyday heart health monitoring.

"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 Manav Bhushan, co-founder and CEO of Fourth Frontier. “The percentage of population that falls in the confluence of these categories is continuously rising. 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 the early detection of cardiovascular disease.”

Related Links:
Fourth Frontier