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.


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

Related Content

News | Cardiac Diagnostics

November 10, 2021 — Abbott released new global market research from its Beyond Intervention initiative, the company’s ...

Home November 10, 2021
Home
Feature | Cardiac Diagnostics | By Dave Fornell, DAIC Editor

October 29, 2021 — A new guideline for the evaluation and diagnosis of chest pain was released this week that provides ...

Home October 29, 2021
Home
News | Cardiac Diagnostics

October 4, 2021 – Nanowear, a hospital-at-home and remote diagnostic platform that used proprietary wearable cloth ...

Home October 04, 2021
Home
News | Cardiac Diagnostics

September 28, 2021 — Biotricity Inc., a medical diagnostic and consumer healthcare technology company, has developed a ...

Home September 28, 2021
Home
News | Cardiac Diagnostics

July 29, 2021 — A recent clinical study from Overlake Medical Center utilizing the Bardy Diagnostics Carnation ...

Home July 29, 2021
Home
News | Cardiac Diagnostics

July 1, 2021 — The U.S. Food and Drug Administration (FDA) has cleared the Angel Medical Systems Inc. second-generation ...

Home July 01, 2021
Home
News | Cardiac Diagnostics

March 8, 2021 — In a new study from Shiley Eye Institute at UC San Diego Health, researchers have identified a potential ...

Home March 08, 2021
Home
News | Cardiac Diagnostics

March 3, 2021 — AliveCor recently announced a new collaboration with AstraZeneca to research new disease management ...

Home March 03, 2021
Home
News | Cardiac Diagnostics

February 2, 2021 — A new study has found in the U.S. shows higher economic prosperity was associated with a small ...

Home February 02, 2021
Home
News | Cardiac Diagnostics

January 6, 2021 — Smoking traditional cigarettes in addition to using e-cigarettes results in harmful health effects ...

Home January 06, 2021
Home
Subscribe Now