LifeWatch has scored another clearance from the FDA, this time for its continuous Vital Signs Monitoring Service.
The company’s wireless, patch-based system makes vital signs monitoring faster, easier and more convenient for both patients and medical staff. It allows for early detection of vital sign changes, thereby enabling faster interventions as well as increased nursing efficiency and higher patient satisfaction.
The Vital Signs Patch, which is also FDA cleared, is an easy-to-use cable-free sensor worn on a patient’s upper chest. It is intended to be used on adult patients in a clinical environment for the continuous, non-invasive monitoring of ECG, heart rate, respiration rate, surface temperature, arterial blood oxygen saturation and body position. The product will be available in two versions (with and without ECG) and is connected with a wireless supporting system that provides medical information and alerts remotely to medical staff.
“This clearance represents another significant technological breakthrough for LifeWatch and further strengthens our position as an innovational leader in digital health,” Dr. Stephan Rietiker, CEO of LifeWatch, said in a statement. “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.”
Last month, LifeWatch’s Mobile Cardiac Telemetry Patch got both the CE Mark and clearance from the FDA.