• CryoLife (Kennesaw, Georgia) said the FDA has cleared a new claim for the CryoValve SG pulmonary human heart valve. The new labeling claim relates to reducing a component of the immune response in recipients of the CryoValve SG. CryoValve SG pulmonary human heart valve is processed with the company's SynerGraft technology, which is designed to remove allogeneic donor cells and cellular remnants from the valve without compromising the integrity of the underlying collagen matrix. The new claim relates to the fact that data from three company-sponsored clinical studies and a comprehensive review of the scientific literature on allograft heart valves shows that implantation of the CryoValve SG reduces the risk of inducing HLA class I and class II alloantibodies, based on Panel Reactive Antibody measured at up to one year, compared to the standard- processed pulmonary human heart valve. The CryoValve SG pulmonary human heart valve is indicated for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary valves. The valve can be used in conjunction with right ventricular outflow tract reconstruction procedures, commonly performed in children with congenital heart defects.

• Sensiotec (Atlanta) reported FDA clearance for the Preventa, an ultra-wideband, non-contact, continuous monitor for heart and respiration rates, bed occupancy and movement. Preventa 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. Preventa also alerts caregivers when a patient requires an assisted relocation to help prevent bed sores, and tracks roaming physical assets and protects wandering at-risk patients (locking exit doors or elevators automatically).

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