Renal Denervation to Control Blood Pressure, Dream Sock Baby Monitor Get FDA Nods

More than two months after an agency advisory panel endorsement, the FDA approved Recor Medical’s ultrasound renal denervation system (RDN) to treat hypertension. The FDA’s Circulatory System Devices Panel endorsed the Paradise system in August, despite differences in opinion on long-term benefits.

Developed as an alternative to traditional high blood pressure treatments and medications, Recor’s Paradise RDN uses radiofrequency ablation to disrupt the performance of the sympathetic nerves surrounding the renal arteries, reducing the overactivity that can lead to hypertension.

Also, this week, A sock that performs pulse oximetry measurement for infants will be available OTC for U.S. consumers by the end of this year, following the FDA’s Wednesday De Novo clearance of Owlet’s Dream Sock baby monitor.

The device met independent lab safety standards following testing in both home and hospital settings, the company said, with accuracy compared with medical-grade baby monitoring technology. The Dream Sock also monitors and displays pulse rate and oxygen saturation levels for infants 1 to 18 months of age, and will alert caregivers with lights and alarms if their infant’s readings measure beyond preset ranges.

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