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VivaLNK Wearable, Reusable ECG Now FDA Cleared

VivaLNK, a company out of Silicon Valley, has announced FDA clearance for its reusable multi-vital patch and a compatible software development kit. The device is stuck to the skin to record ECG waveforms, respiratory rate, heart rate, RR interval, and patient movement, and so has promise in helping to detect cardiac arrhythmias such as atrial fibrillation. Weighing in at only .26 ounces (7.5 grams), it has all the electronics of a single lead ECG, an accelerometer, a rechargeable battery, and wireless connectivity. It was cleared in the EU just last month.

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.

The big selling point for VivaLNK for this monitor may be the software development kit that it comes with, which lets developers easily create new applications using the wearable monitor. The previously cleared VivaLNK temperature monitor can also be used by developers along with the ECG patch.

“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,” said Jeff Pompeo, President and CEO of Caretaker Medical, Charlottesville, Virginia, in a VivaLNK press release.

Product page: VivaLNK Multi Vital ECG Sensor

Related: Software Development Kit (SDK) for VivaLNK sensors

Flashback: VivaLNK’s Tiny Reusable and Wearable ECG Cleared in Europe; Fever Scout Wireless Stick-On Thermometer FDA Cleared; Medgadget @ CES 2016 Recap: Sensors Upon Sensors

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