Two innovative electrocardiogram (ECG) products have gained new US Food and Drug Administration (FDA) clearances for monitoring cardiac arrhythmias—Fourth Frontier’s Frontier X Plus (FX+) and SmartCardia’s seven-lead (7L) patch. Both clearances were announced by the respective companies on 13 November.
“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 chief executive officer (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 gamechanger and significantly improve the early detection of cardiovascular disease.”
The FX+ device is described by Fourth Frontier as an innovative, single-lead, continuous ECG monitor that is worn around the chest and wirelessly—and “instantly”—relays the user’s ECG to remote dashboards. A range of advanced algorithms then identify and classify the patient’s cardiac rhythm as bradycardia, tachycardia, normal sinus rhythm, or atrial fibrillation (AF).
The device has demonstrated best-in-class signal quality during a range of motions, including during intense exercise, the company claims, also stating that—through clinical trials in India and the USA—its wearable ECG monitor further demonstrated equivalence in the classification of cardiac arrhythmias when compared with a conventional 12-lead ECG.
With its recent clearance, Fourth Frontier plans to enter the US market as a prescription-based, class-two medical device. The company will partner with independent diagnostic testing facilities (IDTFs) and cardiac rehabilitation centres to offer at-home remote monitoring services as well, and—in the near future—also plans to introduce artificial intelligence (AI) algorithms that analyse the ECG for early diagnosis of different kinds of heart conditions.
In its own announcement, SmartCardia notes that its 7L live ECG monitoring patch and cloud platform—now FDA-cleared for mobile outpatient cardiac telemetry (MCT/OCT)—is easy to wear, cable-free, waterproof, and can be used for continuous monitoring for up to 14 days. The company further states that this comes shortly after its prior FDA clearance relating to Extended Holter, Event and Holter monitoring. With this latest approval, SmartCardia’s solution can be used in the remote live monitoring of patients’ ECGs and to “immediately notify clinicians for important arrhythmias”, the company claims.
The SmartCardia patch and cloud platform is said to be a single solution for complete cardiology practice—the patch can be used in any of the modes from Holter to mobile telemetry, and can also be remotely, “seamlessly” transitioned between them for patients. The seven ECG leads are streamed live to the cloud, where an ECG is “immediately available”. The proprietary cloud platform analyses the ECG live to provide outpatient telemetry notifications and full-disclosure ECG analysis. The 7L platform also features a real-time view of the patient’s ECG, and can deliver visual and audio alarms, according to SmartCardia.
“SmartCardia’s platform effectively addresses the primary needs of today’s electrophysiologists and cardiologists,” said Jag Singh (Harvard Medical School/Massachusetts General Hospital, Boston, USA), principal advisor of SmartCardia. “Its seven-lead ECG delivers unparalleled clinical accuracy, the live monitoring allows for immediate notifications, and the reusable sensor with a low-cost disposable patch promotes high operational efficiency.”
“Many products available on the market do not have explicit FDA clearance for outpatient cardiac telemetry,” added Adam Kirchgessner, SmartCardia’s US vice president of sales. “Our patch and cloud platform are designed from the ground up to meet stringent outpatient telemetry standards, and this clearance validates our commitment and efforts. With an end-to-end patch to cloud, our solution provides accurate and on-time detection of arrhythmia events.”
