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news.Sensiotec, a developer of wireless medical monitoring devices, has received the FDA 510(k) class II clearance for the ultra-wideband non-contact, continuous monitor for heart and respiration rates, bed occupancy and movement.
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Under the brand name Preventa, Sensiotec will market and sell the medical device in the US 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.
According to the company, Preventa is the first medical device to harness the potential of ultra-wideband (UWB), an emerging wireless communications standard and former classified military technology, creating a wireless vital signs monitor.
Robert Arkin, CEO of Sensiotec, said: “We’re excited by the opportunity with Preventa to make a difference in people’s lives through improved disease management while also addressing society’s need to help contain runaway healthcare costs.”