(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."

Gilead Receives Response From U.S. FDA On Company's Request For Formal Dispute Resolution For Aztreonam For Inhalation ... (Medical News Today)
Gilead Sciences, Inc. (Nasdaq:GILD) announced that the company has received a response from the U.S. Food and Drug Administration (FDA) to its appeal, submitted under the formal Dispute Resolution process, regarding the Agency's Complete Response Letter for its New Drug Application (NDA) for aztreonam for inhalation solution.

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).