News | January 22, 2020

FDA Clears VivaLNK Wearable ECG Sensor Platform

Reusable patch and software development kit gives solution providers direct control over data

The VidaLink wireless, remote, wearable ECG patch patient monitor.  It consisting of reusable wearable electrocardiogram (ECG) sensors and associated 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.

The VidaLink wireless, remote, wearable ECG patch patient monitor.  It consisting of reusable wearable electrocardiogram (ECG) sensors and associated 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. Photo of the device on display at HIMSS 2019. Photo by Dave Fornell.

January 22, 2020 — The U.S. Food and Drug Administration (FDA) cleared VivaLNK's Continuous ECG Platform. It consisting of reusable wearable electrocardiogram (ECG) sensors and associated 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.

One of the key issues surrounding medical internet-of-things (IoT) solutions is data control. There are questions about who owns the data and where it is stored. Most wearable medical devices that offer remote access force application developers and solution providers to use a third-party cloud for access.

"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.

For more information: www.vivalnk.com/product/multi-vital-ecg

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