FDA nod for LifeWatch wireless, patch-based vital signs monitoring system

Swiss remote diagnostic monitoring company LifeWatch ($LIFE) has secured a clearance from the FDA for its wireless, patch-based vital signs monitoring system. It's expected to be used first in medical facilities such as hospitals and nursing homes, but eventually the company expects to target the ambulatory care market as well.

The Vital Signs Patch is worn on a patient's upper chest. In adult patients in a clinical environment, it offers continuous, noninvasive monitoring of ECG, heart rate, respiration rate, surface temperature, arterial blood oxygen saturation and body position. It will be available in two versions, with and without the ECG component.

"This clearance represents another significant technological breakthrough for LifeWatch and further strengthens our position as an innovational leader in digital health. I am highly excited at the tremendous market potential for the easy-to-use Vital Signs Patch, both in the clinical and ambulatory settings worldwide," LifeWatch CEO Dr. Stephan Rietiker said in a statement.

"Furthermore, the cost benefits will allow vital signs monitoring to be utilized for a much broader patient population," he continued. "However, providing service in a clinical environment is a new market for LifeWatch and will therefore require both time and additional resources in order to ensure a successful market launch."

The patch was previously cleared by the FDA; this clearance is for the continuous Vital Signs Monitoring Service that works in tandem with it.

LifeWatch specializes in mobile cardiac telemetry and cardiac monitoring technologies and services. Last month, it partnered with AliveCor to integrate its patch-based ECG monitoring technology into its own cardiac monitoring products. It also got a clearance for its single-lead Mobile Cardiac Telemetry (MCT) Patch from FDA in January.

"Digital health monitoring is revolutionizing how people interact with healthcare delivery. The AliveCor Mobile ECG will enable LifeWatch to broaden its cardiac event monitoring services, whilst at the same time opening the door to post-event cardiac monitoring via a patient's own mobile device," commented Rietiker at the time of the AliveCor deal. "This will provide the patient with greater control and convenience. At the same time, physicians will benefit from a broader range of attractive, diagnostic options."

- here is the announcement

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