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FDA Approvals - Medtronic Receives FDA HDE Approval To Commercialize The First Deep


Medtronic Receives FDA HDE Approval To Commercialize The First Deep Brain Stimulation Therapy For A Psychiatric ... (Medical News Today)
Medtronic, Inc. (NYSE: MDT), announced its official entrance into psychiatric therapies with approval from the U.S. Food and Drug Administration (FDA) for a humanitarian device exemption (HDE) for its Reclaim Deep Brain Stimulation (DBS) Therapy for chronic, severe obsessive - compulsive disorder (OCD).

Aurobindo gets US FDA nod for Tenofovir Disoproxil Fumarate pills (PharmaBiz)
Aurobindo Pharma has received tentative approval for Tenofovir Disoproxil Fumarate tablets, 300 mg from the US Food and Drug Administration (USFDA).

(AFX UK Focus) 2009-02-19 16:50 U.S. FDA approves Medtronic brain device (Interactive Investor)
WASHINGTON, Feb 19 (Reuters) - U.S. health officials approved Medtronic Inc's deep brain stimulator to help treat patients with severe obsessive-compulsive disorder, or OCD. The device, Reclaim DBS Therapy, was cleared on Thursday under the agency's human device exemption policy, the FDA said. Under such approvals, Medtronic had to show the device was safe and offered "probable benefit."
 

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