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FDA Approvals - TrimGen Corporation Received FDA 510(k) Approval For Warfarin Genotyping Kit


TrimGen Corporation Received FDA 510(k) Approval For Warfarin Genotyping Kit (Medical News Today)
TrimGen Corporation, a molecular diagnostic company, announced that it has received FDA 510(k) clearance to market its eQ-PCR(TM) LC Warfarin Genotyping kit. This assay is to be used as an aid in the identification of patients who may be at risk of warfarin sensitivity.

FDA Approves Humanitarian Device Exemption For Deep Brain Stimulator For Severe Obsessive-Compulsive Disorder (Medical News Today)
The U.S. Food and Drug Administration approved a humanitarian device exemption for the first implantable device that delivers intermittent electrical therapy deep within the brain to suppress the symptoms associated with severe obsessive-compulsive disorder (OCD). The U.S.

SafeStitch Medical, Inc. Announces FDA Approval To Market Its SMART DilatorTM (Medical News Today)
SafeStitch Medical, Inc. (OTCBB:SFES) announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's 510(k) application to begin U.S. marketing of its SMART DilatorTM, the first esophageal dilator to indicate the pressure level being applied at the esophageal stricture.
 

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