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FDA Proposes Informed Consent Exceptions for Emergencies
FDAnews - Saturday, September 02, 2006
The FDA may be making life easier for researchers conducting studies in emergency settings when patients are unable to give their informed consent, issuing a draft guidance on informed consent exceptions Aug. ... more

Inspection Uncovers Mold Growth, Leads to Warning Letter
FDAnews - Saturday, September 02, 2006
An in vitro diagnostic manufacturer failed to investigate root causes of nonconformances, including fungus and mold growth, the FDA said in a recent warning ... more

FDA Cites Inadequate Examination Procedure for Blade System
FDAnews - Saturday, September 02, 2006
An inspection of Medisurg Research & Management’s facilities led to a warning letter regarding the Fugo Blade System, a battery-operated cutting apparatus used for capsulotomy, glaucoma and peripheral ... more

Informed Consent Form Problems Lead to Warning Letter
FDAnews - Saturday, September 02, 2006
Failure to obtain informed consent and schedule required follow-up visits with device clinical trial subjects led to a warning letter for clinical investigator Barry Eppley of the Riley Hospital for Children, ... more

Third-Party Audit Leads to Stricter Regulation Enforcement
FDAnews - Saturday, September 02, 2006
Regulation violations including improper audit procedures prompted the FDA to issue a warning letter to Sonotech, an ultrasound gel ... more

Cardinal Health Removes Pumps From Market After Seizure
FDAnews - Saturday, September 02, 2006
Cardinal Health Aug. 28 announced it had suspended production, sales, repairs and installations of its Alaris SE infusion pump after the government seized approximately 1,300 of the devices Aug. ... more

Irish Device Group Seeks Small Business Status
FDAnews - Saturday, September 02, 2006
The Irish Medical Devices Association (IMDA), which falls within the Irish Business and Employers Confederation, has called for “a concerted effort to be made across Europe” to establish a system to enable small EU-based device and diagnostic companies to benefit from fee reductions when registering new product applications with the ... more

Briefs
FDAnews - Saturday, September 02, 2006
... more

Device Recalls
FDAnews - Saturday, September 02, 2006
... more

FDA PARTNERS WITH MIT TO DEVELOP DEVICE-TRACKING DATABASE
FDAnews - Saturday, September 02, 2006
The FDA is partnering with the Massachusetts Institute of Technology (MIT) to develop new databases to monitor devices and drugs after they have been ... more


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CEPHEID WINS $3.3 MILLION NIAID GRANT TO DEVELOP RAPID TB TEST
FDAnews - Saturday, September 02, 2006
Cepheid said Aug. 30 it had won a $3.3 million grant from the National Institute of Allergy and Infectious Diseases (NIAID) to develop rapid detection technology for tuberculosis ... more

SAFETY ALERT ISSUED FOR MEDICAL EQUIPMENT CLEANING DEVICES
FDAnews - Saturday, September 02, 2006
The FDA and Steris have issued a MedWatch safety alert for two devices used to clean reusable medical ... more

MEDTRONIC DEVICE EFFECTIVE IN PARKINSON'S TRIAL
FDAnews - Saturday, September 02, 2006
Medtronic Inc.'s Activa brain stimulation device, combined with medication, improves motor functions and quality of life in patients with advanced Parkinson's disease more than in patients receiving only medication, according to a study published in Thursday's issue of the New England Journal of ... more

NEW DEVICE MAY IMPROVE VISION AND MOBILITY FOR PEOPLE WITH TUNNEL VISION
FDAnews - Saturday, September 02, 2006
Scientists at Schepens Eye Research Institute, an affiliate of Harvard Medical School, say a visual aid they invented promises to improve the visual abilities of people with tunnel ... more

GENETIC TESTING COMPANY STRIKES JAPAN DEAL
FDAnews - Saturday, September 02, 2006
A small Morrisville company that is working to make drugs safer in the U.S. is reaching out to Japan as a first step in strengthening its worldwide ... more

SMILING SYRINGES LESS THREATENING
FDAnews - Saturday, September 02, 2006
Smiley faces, fish, suns and many other stickers were used to decorate medical devices and reduce patients' fear of them, according to a study done by researchers at UNM's Health Sciences ... more

SEAT BELT TO PROTECT IMPLANTED MEDICAL DEVICES
FDAnews - Saturday, September 02, 2006
Pressure Products has launched the SoftTouch device for attaching to a seat belt to reduce impact forces over an implantable device when the wearer is in a vehicle ... more

FISH FATTY ACIDS MAY PREVENT MORE SUDDEN DEATHS THAN DEFIBRILLATORS
FDAnews - Saturday, September 02, 2006
Omega-3 fatty acids may prevent more sudden deaths than automated external defibrillators in homes and public places or implanted defibrillators, according to the results of a new ... more

Refugees Beginning Returning Home But Many Still Reluctant
allAfrica.com - Saturday, September 02, 2006
Nearly half of the 40,000 refugees who fled Togo during post-election violence last year have left refugee camps in Benin and Ghana, and the Togolese government says it plans to repatriate those ... more

Starlets Show Spark of Black Stars in Friendly
allAfrica.com - Saturday, September 02, 2006
The national Under-17 football team, the Black Starlets beat their Benin counterparts, US Seme KRAKE 3-1 in an international friendly match at the Sunyani Coronation Park on ... more

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