LifeWatch gets FDA clearance for adhesive, remote patient monitoring wearable

By Jonah Comstock
Share
Vital Connect's HealthPatch, which partnered with LifeWatch last month Vital Connect's HealthPatch, which partnered with LifeWatch last month

Swiss remote cardiac monitoring company LifeWatch has received FDA 510(k) clearance for LifeWatch VSP (Vital Signs Patch), the company's adhesive patch for remote patient monitoring.

"Being small in size, easy to affix, comfortable to wear and far less restrictive and cumbersome than numerous wired devices currently used, the VSP will work in hospital, ambulance, nursing care and home environments, replacing multiple hardware devices with a far more comfortable and cost effective approach to care," LifeWatch wrote in a press release in October 2013, when the company originally submitted the device for clearance. "Parameters can be customized and set for alerts; data can be configured and accepted into an EMR system." 

The device is a disposable adhesive strip which contains sensors to monitor ECG, heart rate, respiration rate, temperature, saturation, and movement. It also contains a battery which allows the device to collect data continuously for five to seven days. The clearance is for the whole VSP system, which also includes a wireless connected blood pressure cuff and an Android app that processes and transmits the data. The app can also monitor the patient and generate alerts in the event of unusual vital signs.

"The VSP patch will also enable a more efficient use of health system resources in hospitals as nursing staff can focus on their core strength," the company wrote last year. "Routine procedures can be handled fast and effectively via the VSP limiting human errors and improving medical quality. In emergency medicine, the VSP patch offers additional benefits: The patch is immediately applied at the emergency site to capture, analyze and transmit relevant medical data to the hospital. All necessary hospital resources can then be deployed before the patient arrives, saving valuable time to start the emergency treatment."

In November 2014, while LifeWatch was still awaiting FDA clearance, the company partnered with Vital Connect to use that company's HealthPatch technology in its cardiac monitoring business. Vital Connect's HealthPatch is also an adhesive, disposable cardiac monitor. The two companies planned to bring an integrated solution to market in the first half of 2015. With LifeWatch gaining clearance for its own device, it's unclear whether it will discontinue the relationship with Vital Connect or use a combination of monitoring devices in different use cases.

MobiHealthNews has reached out to LifeWatch for comment and will update this story when we hear back.