Simplifying Global Compliance
The FDA is creating tough new standards for clinical trials that use live case presentations, requiring that devicemakers discuss all potential risks and benefits in their investigational plans. Read More
The FDA is setting new endotoxin limits for several types of single-use intraocular ophthalmic devices. Read More
Varian Medical Systems will pay the University of Pittsburgh $35 million to settle claims that its Real-Time Position Management device infringed on a patent held by the university. Read More
A Minnesota-based unit of Endo Health Solutions has landed an FDA warning letter, the Irish devicemaker says in a Wednesday SEC filing. Read More
Heart patients in the U.S. would no longer have access to Medtronic’s CoreValve transcatheter valve if a preliminary injunction handed down in federal court takes effect. Read More
Laparoscopic devices commonly used to treat uterine fibroids could spread cancerous tissue, the FDA said Thursday in a safety communication discouraging the use of the procedure. Read More
FzioMed will get to argue its case for Oxiplex spine surgery gel before the FDA’s Dispute Resolution Panel on June 10. Read More
LumiQuick Diagnostics received an FDA warning letter after an investigator saw employees assembling a drugs of abuse test panel and an amphetamine test strip on the same table. Read More
The FDA has granted Quidel an emergency use authorization for its Lyra Influenza A Subtype H7N9 assay. Read More
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