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A group of mental health professionals, trauma researchers, ethicists and IRB representatives have published a set of ethical guidelines for research with victims of disasters.
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Community-based research requires a special type of review, and so should have its own type of review board, one that balances the responsibilities that IRBs have to individuals with an appreciation for the needs of the community in which research is conducted.
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As the current debate over the safety and efficacy of drug-eluting stents demonstrates, veins and arteries aren't simply plumbing - or at least not the kind of plumbing that can be fixed in a one-fix-fixes-all strategy.
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CVRx (Minneapolis) received FDA approval for conditional investigational device exemption (IDE) for its Rheos baroreflex hypertension therapy system, an implantable device to treat high blood pressure.
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The Heart Rhythm Society (HRS; Washington) last month issued its long-awaited list of recommendations for reporting malfunctions and adverse events for cardiac rhythm management devices, with a considerable level of detail for physicians, industry and the FDA.
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For only the second time since its creation, the FDA's Medical Devices Dispute Resolution Panel (MDDRP) will determine the fate of a company's technology.
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Signaling what it said is a "new frontier in the use of transcatheter valve technology," Medtronic (Minneapolis) has received the CE mark for its Melody transcatheter pulmonary valve with Ensemble transcatheter delivery system.
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In a move that may augur a more concentrated focus in the medical device market, pharmaceutical powerhouse Merck (Whitehouse Station, New Jersey) last month agreed to acquire a roughly 11% stake in FoxHollow Technologies (Redwood City, California) and expand the scope of their existing collaboration for atherosclerotic plaque analysis.
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In a move based primarily on clinical data, Abbott Laboratories (Abbott Park, Illinois) last month reported that it was scrapping its ZoMaxx drug-eluting stent (DES) program and launching the...
