FDA has cleared VivaLNK's continuous ECG platform. Consisting of reusable wearable ECG sensors and associated software development kit, the sensor platform gives developers and providers direct control over data, and represents the first of its kind to receive FDA clearance, according to the Campbell, CA-based company.
With the VivaLNK platform, application developers can integrate with VivaLNK medical wearable sensors and send that data directly to the application, the company said. In addition, the VivaLNK sensor does not collect personally identifiable information.
The software development kit 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, VivaLNK noted. That enables multiple vitals to be remotely monitored from a single platform.