Sensiotec Announces FDA 510(k) Class II Clearance for the World’s First UWB Healthcare Unbound, Wireless, Non-Contact, Vital Signs and Movement Monitor Device

ATLANTA, Feb. 11 /PRNewswire/ — Sensiotec Inc. announces FDA 510(k) Class II clearance for the world’s first ultra-wideband (UWB) non-contact, continuous monitor for heart and respiration rates, bed occupancy and movement. Under the brand name Preventa(TM), 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.

Preventa(TM) is the first medical device to harness the potential of UWB, an emerging wireless communications standard and former classified military technology, creating a wireless vital signs monitor. In 2002, the FCC authorized the use of UWB for the development of new imaging systems to “see” inside the human body. Sensiotec CEO Robert Arkin states, “We’re excited by the opportunity with Preventa(TM) to make a difference in people’s lives through improved disease management while also addressing society’s need to help contain runaway healthcare costs.”

Preventa(TM) monitors heart and respiration rates, bed occupancy and movement on a continuous, real-time, remote basis, “watching” patients 100% of the time from a monitoring station down the hall or even 1,500 miles away. Caregivers gain a disease management tool that can help reduce complications associated with common chronic illnesses (such as heart disease, COPD and sleep apnea), optimize scarce human resources, and reduce hospital admissions and ER visits. Preventa(TM) also alerts caregivers when a patient requires an assisted relocation to help prevent bed sores. Using additional proprietary components, Preventa(TM) tracks roaming physical assets and protects wandering at-risk patients (locking exit doors or elevators automatically). Sensiotec CTO Efraim Gavrilovich states, “Wireless monitoring has great potential as an early warning system that helps to identify and manage health crises when they arise.”

Company Background

Sensiotec Inc. is a development stage company based in Atlanta, Georgia. Sensiotec’s value proposition is to commercialize next-generation wireless medical monitoring devices that improves healthcare quality and safety, and reduces costs. Sensiotec’s strategic intent is to market Preventa(TM) in 2009.