VivaLnk has secured FDA clearance for its Continuous ECG platform comprising of reusable wearable ECG sensors and associated software development kit (SDK).
The reusable patch and SDK gives solution providers direct control over data.
The company claims it is the world’s first FDA-cleared wearable ECG sensor platform.
The platform allows application developers to combine with VivaLNK medical wearable sensors, forwarding data instantly to the application.
Additionally, the company’s sensors do not gather personal information.
CareTaker Medical president and CEO Jeff Pompeo said: “Caretaker is pleased to select VivaLNK as the FDA 510k 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.”
The SDK in the platform also helps developers to combine with the FDA-cleared and CE-marked VivaLNK temperature sensor, allowing numerous vitals to be remotely observed from a single platform.
AMPS president and chief scientist Fabio Badilini said: “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.”
VivaLNK offers healthcare solutions for wellness, telemedicine and medical treatment.
The company’s portfolio comprises wearable medical grade devices and data analytics applications to examine patient health.
Last August, researchers at Emory University had used VivaLNK’s ambulatory ECG patch to study autonomic function in patients undergoing coronary angiography.