VivaLNK's Wearable ECG Sensor Platform receives FDA 510(k) clearance

Delhi: VivaLNK's Continuous ECG Platform has received the US FDA's 510(k) clearance. It consists of reusable multi-vital patch and a compatible software development kit (SDK). The sensor platform gives developers and providers direct control over data and represents the first of its kind to receive FDA clearance.

Weighing only 7.5 grams, the light, and comfortable patch is designed for continuous monitoring or retrospective analysis. The ECG patch is available with a software development kit that enables easy integration with remote patient monitoring applications whether on location or in the cloud.

Being reusable should help make this wearable patch more attractive for cost-conscious cardiology clinics, as most wireless wearable cardiac monitors with similar capabilities are single-use devices.

Atrial fibrillation (AF), the most common form of arrhythmia, affects up to 6 million people in the United States and 33 million worldwide. Left untreated, AF can lead to a 5X increase in stroke. People over 65 are at most risk, but AF can occur in younger profiles based on health and history. 

"Caretaker is pleased to select VivaLNK as the FDA 510(k) cleared ECG sensor provider for our continuous wireless vital signs platform and thrilled to have a best-in-class form factor that is incredibly comfortable for the patient, easy to integrate into our system, reliable for our healthcare provider customers, and allows direct control of the data flow into our secure CaretakerCloud remote patient monitoring portal," said Jeff Pompeo, president and CEO of Caretaker Medical, based in Charlottesville, Va.

With the VivaLNK platform, application developers can integrate with VivaLNK medical wearable sensors, and send that data directly to the application. In addition, the VivaLNK sensor does not collect personally identifiable information.

"VivaLNK's Continuous ECG Platform has been seamlessly integrated with the AMPS Continuous ECG Recording Suite (CER-S) allowing for the direct analysis of the recorded data, and can therefore be immediately adopted by the pharmaceutical industry in the context of clinical trials," said Fabio Badilini, Ph.D., FACC, president and chief scientist at AMPS.

The SDK in the platform not only allows developers to integrate directly with the wearable ECG sensor, but also integrates with the previously FDA cleared and CE marked VivaLNK temperature sensor. This enables multiple vitals to be remotely monitored from a single platform.

Features of multi-vital ECG patch