Devices & Diagnostics Letter
Aug. 13, 2012
| Vol.
39 No.
32
| Full Issue in PDF Format
The FDA Wednesday said it is limiting use of Stryker’s Wingspan brain stent, but stopped short of removing the device from the market entirely — as consumer advocates had urged.
The Centers for Medicare & Medicaid Services (CMS) is planning to re-examine its coverage standards for ventricular assist devices (VAD), but any changes in the offing are still under wraps.
An FDA warning letter issued to a researcher involved in clinical trials of the first home HIV test is not expected to affect the product’s marketing, officials from the FDA and the test’s manufacturer tell D&DL.
Higher user fees and the FDA’s corresponding pledge to improve performance at CDRH stole the spotlight during the Medical Device User Fee Act (MDUFA) reauthorization process earlier this year.
A Tennessee maker of wheelchair components received an FDA warning letter after the agency determined some products advertised on the company’s website had never been formally approved.
Implantable cardioverter defibrillators (ICDs) may reduce by one-third the need for resuscitation in heart attack patients, a study in the Aug. 6 issue of Circulation finds.
The FDA recently announced the availability of fiscal 2014 grants to support clinical development of orphan devices or drugs.
Stryker Orthopaedics is facing a lawsuit alleging damages caused by the company’s titanium alloy Rejuvenate hip system.
How should devicemakers audit virtual companies that are part of their supply chain? The first step is figuring out who they are, and then tailoring a qualification and audit program for them.
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