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FDA approves spinal cord stimulation system from Biotronik

Biotronik announced today that it received FDA approval for its Prospera spinal cord stimulation (SCS) system. ....

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Functional Neuromodulation Announces Breakthrough Device Designation from the U.S. FDA for Deep Brain Stimulation for Alzheimer's Disease

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MINNEAPOLIS, Jan. 6, 2021 /PRNewswire/ Functional Neuromodulation announced today that it has received Breakthrough Device designation from the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) for the Vercise™ Deep Brain Stimulation (DBS) Systems, developed and manufactured by Boston Scientific Corporation, in the treatment of patients 65 years and older with mild probable Alzheimer s disease. The Breakthrough Device designation will provide priority review regarding device development and assessment to help provide patients and healthcare providers gain timely access to medical devices that provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. ....

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