CVRx, Inc., a privately held medical device company, announced today that it has received Humanitarian Device Exemption (HDE) approval from the U.S. Food and Drug Administration (FDA) for its Barostim neo legacy device. This milestone represents CVRx's first commercial approval in the United States and is based on a determination by the FDA that neo legacy is safe and can be used in U.S. patients who were defined as responders to the Rheos Carotid Sinus Lead System.
"We are excited that our early clinical subjects who are actively being treated in our hypertension feasibility and pivotal studies will be able to maintain access to continued therapy through the HDE approval. All of these patients have been treated for over five years with Barostim Therapy, said Nadim Yared, CEO of CVRx. "During that time, CVRx has remained committed to providing access to Barostim Therapy for patients. My team and I want to thank our investigators, clinical research coordinators, investors, and especially our pioneering patients for their commitment to the therapy. We also want to thank FDA for interactively working with us on this unique approval."
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