Sensiotec has received FDA 510(k) Class II clearance for its ultra-wideband (UWB) non-contact, continuous monitor for heart and respiration rates, bed occupancy and movement.
Under the brand name Preventa, the Atlanta-based Sensiotec said it will market and sell the medical device in the U.S. and Canada under an exclusive worldwide license with its affiliate, Wireless 2000. Wireless 2000 received the sign-off from the FDA's Division of Cardiovascular Devices.
Preventa is a medical device to harness the potential of UWB, a radio technology that can be used at very low energy levels for short-range high-bandwidth communications by using a large portion of the radio spectrum, according to the company. Preventa can monitor heart and respiration rates, bed occupancy and movement on a continuous, real-time, remote basis, watching patients from a monitoring station down the hall or 1,500 miles away, the firm said.