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Full Issue in PDF Format
FDAnews - Saturday, September 09, 2006
View the entire issue in PDF ... more

Firm Breaks Into Japanese Market After Nine-Year Approval Process
FDAnews - Saturday, September 09, 2006
As the Japanese regulatory landscape shifts toward shorter approval times, one firm recently emerged from a nine-year process to tell its tale of what it takes to get a device into the Japanese ... more

Medical Testing Methods Subject of Two Draft Guidances
FDAnews - Saturday, September 09, 2006
The FDA issued two draft guidances Sept. 7 on medical testing: one covering a new type of medical test called in vitro diagnostic multivariate index assays (IVDMIAs), and the other clarifying the rules for commercially distributed active ingredients of medical tests called analyte specific reagents ... more

VeriChip Deals Could Signal RFID Healthcare Boost
FDAnews - Saturday, September 09, 2006
Human-implantable radio frequency identification (RFID) chip manufacturer VeriChip recently made the first sale of its radio frequency infant protection system in Canada and is in talks with the U.S. military about another under-the-skin ... more

FDA Approves ‘Totally Implanted’ Permanent Artificial Heart
FDAnews - Saturday, September 09, 2006
The FDA approved the first “totally implanted artificial heart” for patients with advanced heart failure, the agency announced Sept. ... more

INSPECTION UNCOVERS MOLD GROWTH, LEADS TO WARNING LETTER
FDAnews - Saturday, September 09, 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 DEVICE ADVISORY PANELISTS DROP BALL ON SAFETY, REPORT SAYS
FDAnews - Wednesday, September 06, 2006
A new report uses comments from FDA advisory panel members to show a disconnect between members' safety concerns and device approval ... more

NEW ANALYSIS PROVIDES ADDITIONAL SUPPORT FOR CRT THERAPY FOR PATIENTS WITH HEART FAILURE
FDAnews - Wednesday, September 06, 2006
Data presented Sept. 5 at the European Society of Cardiology/World Congress of Cardiology shows that long-term use of cardiac resynchronisation therapy (CRT) or CRT-D (with an implantable cardioverter defibrillator) is a cost-effective method of increasing survival in patients with heart failure, according to ... more

BIOPHAN LICENSOR ISSUES PATENT ON NANOMAGNETIC COATINGS
FDAnews - Wednesday, September 06, 2006
Biophan Technologies recently announced the issuance of a patent covering nanomagnetic coatings on medical ... more

US, Benin start medical exercises
Topix - Tuesday, September 05, 2006
US, Benin start medical exercises Tuesday September 05, 2006 06:51 - COTONOU - US military medical personnel and the armed forces of Benin have begun medical exercises, kicking off two weeks of joint activities ... ... more


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MTN's Investcom grows revenue
Mail & Guardian (South Africa) - Sunday, September 03, 2006
Investcom, which MTN Group acquired in July 2006 for $5,5-billion, on Wednesday reported a 26% rise in total subscribers to 6,14-million at the end of June. Investcom has operations in Ghana, Syria, Yemen, Sudan, Cyprus, Benin, Guinea Bissau, Guinea Republic and ... more

Full Issue in PDF format
FDAnews - Saturday, September 02, 2006
View the entire issue in PDF ... more

FDA Device Advisory Panelists Drop Ball on Safety, Report Says
FDAnews - Saturday, September 02, 2006
A new report uses comments from FDA advisory panel members to show a disconnect between members’ safety concerns and device approval ... more

Demographic Trends Favor Devices to Treat and Monitor Sleep Apnea, Analysts Say
FDAnews - Saturday, September 02, 2006
An aging U.S. population and increasing rates of obesity are contributing to a positive market outlook for devices to treat and monitor sleep apnea, analysts ... more

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

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