Minnesota’s CVRx Receives FDA Approval for World’s First Heart Failure Neuromodulation Device



Via News Release

CVRxMINNEAPOLISAug. 16, 2019 /PRNewswire/ — CVRx, Inc., a private medical device company, announced today that it has received Premarket Approval (PMA) from the United States Food and Drug Administration (FDA) to market its BAROSTIM NEO device for heart failure in the United States. The FDA’s Center for Devices and Radiological Health (CDRH) approved the Company’s submission after a thorough review of the clinical trial data from the Baroreflex Activation Therapy for Heart Failure Pivotal Trial (BeAT-HF).