Wearable sensor company VivaLNK got the FDA nod for its Multi Vital ECG Sensor and software development kit (SDK) this morning.
This comes roughly a month after the technology landed a CE Mark, allowing the product to be marketed in the European Union.
The new product, which includes a light weight reusable sensor and corresponding SDK, allows developers and providers to have direct control over data because it eliminates the need for a third-party cloud for access, according to the company.
Researchers and clinicians can use the technology to continuously stream a patient’s ECG rhythm, respiratory rate, heart rate, RR interval and three-axis acceleration. The SDK includes a reusable ECG Patch, charging case, disposal adhesives, documentation, ample app and software API.
WHY IT MATTERS
Heart disease is the leading cause of mortality in the US, accounting for one in every four deaths, according to the CDC. ECGs and other vital signs can detect heart problems. The new tech is pitched as a way to monitor cardiac signals and other vitals in a secure way.
"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," Jeff Pompeo, president and CEO of Caretaker Medical, a VivaLNK partner, said in a statement.
THE LARGER TREND
The push for remote monitoring tools dates to the early days of digital health. Some of the biggest names in the field today include VitalPatch, iRhythm and Bardy Diagnostics, the latter of which raised $35.5 million for its remote monitoring patches last year.
VivaLNK has been in the game since 2014, and scored its first FDA clearance for a peel-and-stick continuous thermometer called Fever Scout back in 2017. More recently the company made a deal with Scottish company Current Health, which has tapped VivaLNK to bring axillary temperature and spirometry measurements capabilities to its offerings.