FDA approves wearable ECG sensor platform

VidaLink wearable ECG patch patient monitor
The FDA has approved the VidaLink wireless, remote, wearable ECG patch patient monitor. (Dave Fornell)

The U.S. Food and Drug Administration (FDA) has given clearance to VivaLNK's Continuous ECG Platform. The platform comprises reusable wearable electrocardiogram (ECG) sensors and associated software development kit (SDK). It gives developers and providers direct control over data, and reportedly represents the first of its kind to receive FDA clearance.

A key issue surrounding medical internet-of-things (IoT) solutions is data control. Most wearable medical devices that offer remote access force application developers and solution providers to use a third-party cloud for access.

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.

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"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, in a statement.

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.

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