Swiss remote diagnostic monitoring company LifeWatch said today it received FDA 510(k) clearance for its Vital Signs monitoring service.
The service operates using wireless, patch-based vital signs monitors to allow for early detection of vital signs to enable more timely interventions, which the company claims leads to increased nursing efficiency and higher patient satisfaction.
“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. Furthermore, the cost benefits will allow vital signs monitoring to be utilized for a much broader patient population. 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,” CEO Dr. Stephan Rietiker said in prepared remarks.
The Vital Signs patches are cable-free sensors worn on a patient’s upper chest, and intended for use by adult patients in clincial environments for continuous, non-invasive monitoring of ECG, heart rate, respiration rate, surface temperature, arterial blood oxygen saturation and body position, the company said. The patch will be released in 2 versions, with or without ECG.
The company said it plans to offer the system initially to medical facilities, following with the larger ambulatory market once the tech has been “proven in the clinical environment.”
In January, LifeWatch won 510(k) clearance from the FDA for its mobile cardiac telemetry patch, a 1-lead electrocardiograph system.
Zug, Switzerland-based LifeWatch said the MCT 1-lead patch is capable of “watching every heartbeat for adverse cardiac events and transmitting significant findings, in near-real time, to a clinical service center.”