Respicardia's remedē Neurostimulator Improves Sleep Apnea Symptoms In Pivotal Trial
The implantable neurostimulation system works automatically and continuously during every hour of sleep and does not depend on patient adherence, which has been a major limitation of continuous positive airway pressure therapy.
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The US Medicare agency granted inpatient new-technology add-on payments for Boston Scientific's newly acquired cerebral protection system for TAVR, Respicardia's neurostimulator for sleep apnea and Procept BioRobotics' novel resection system for benign prostatic hyperplasia. The highly selective bonus payments typically help drive adoption for the chosen new technologies.
This month's edition of Device Debuts includes new product launches from Medtronic, Cochlear, Qualcomm, Titan Spine, Stryker, Philips, Nuance, Nevro, Siemens, Vortex BioSciences, ResMed, Respircardia, and others.
The volume of original PMAs coming to US FDA for review is down recently, while panel-track supplement, de novo and 510(k) volumes are up. October, meanwhile, was a relatively light month for novel device approvals, but better-than-average for 510(k) clearances.