LifeWatch gets FDA clearance for Vital Signs Monitoring service
February 8, 2016 – ZUG. LifeWatch AG, a leading developer and provider of medical solutions and remote diagnostic monitoring services in the digital health market, is pleased to announce that it has received FDA clearance for its continuous Vital Signs Monitoring Service.
The wireless, patch-based vital signs monitoring system makes vital signs monitoring faster, easier and more convenient for both, patients and medical staff. It will allow 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 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. It will be available in two versions (with and without ECG) and is connected with an easy-to-use wireless supporting system, which provides medical information and alerts remotely to medical staff. Although the system will initially be used in a medical facility (hospital, nursing home, etc.), the even larger ambulatory market should follow once the technology has been proven in the clinical environment.
Dr. Stephan Rietiker, CEO of LifeWatch, stated: “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.”
Source: LifeWatch AG