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In addition to treating movement disorders such as Parkinson’s disease, essential tremor and dystonia, Medtronic will now be able to treat obsessive compulsive disorder (OCD) in a select subset of patients due to a recent FDA humanitarian use device (HUD) designation.
The widespread use of electronic data capture (EDC) technology is helping Novartis Pharmaceuticals cut down on errors during the clinical trial process and achieve research savings approaching $100 million annually.
Widespread use of electronic data capture (EDC) technology is helping Novartis Pharmaceuticals cut down on errors during the clinical trial process and achieve research savings approaching $100 million annually.
Medtronic has introduced its Attain Select 6238 TEL Guide Catheter Set, which aids in the safe and effective implantation of device leads in the veins that serve the left side of the heart for the treatment of heart failure.
The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), has released its "GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures."
The FDA has selected GlobalNet Services (GNSI) of Rockville, Md., in partnership with Cyclone Commerce of Scottsdale, Ariz., to build the Electronic Submissions Gateway, a central collection portal for esubmissions from FDA-regulated industries and other government agencies, the companies announced recently.
Devicemaker Medtronic voluntarily notified doctors about faulty batteries in select lines of its implantable cardioverter-defibrillators, saying that the batteries, which normally have a five- to six-year lifespan, may lose all their power from within a few hours to a few days.
Purdue Pharma of Stamford, Ct., has purchased 100 mobile radio-frequency identification (RFID) systems that it plans to donate to law enforcement and cargo-theft investigative agencies to fight drug counterfeiting, Purdue and Symbol Technologies, a Holtsville, N.Y.-based mobile technology vendor, announced Feb. 14.
The FDA’s Electronic Submissions Gateway moved a step closer to reality last week when the agency selected the vendors that will build the system, a central collection portal for electronic submissions from FDA-regulated industries and other government agencies.
Medical products company B. Braun has introduced the LidoSite Topical System to help reduce needlestick pain associated with procedures such as intravenous cannulation, venipuncture or laser ablation of superficial skin lesions in patients age 5 and older.