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Percutaneous coronary intervention (PCI) — often involving stents — coupled with drugs is no better at reducing major cardiovascular events than drugs alone, according to a new study.
Abbott Laboratories has “the best stent,” RBC Capital Markets analysts said after data released last week at the American College of Cardiology’s 56th Annual Scientific Session indicate Abbott’s Xience stent is superior to Boston Scientific’s Taxus stent.
Rather than giving the FDA new regulatory authority, as has been suggested by some lawmakers and the Institute of Medicine, government decisionmakers need to give the agency more funding, the agency’s outgoing deputy commissioner for medical and scientific affairs told D&DL.
The FDA wants industry feedback in response to new recommendations made by World Health Organization (WHO) experts that would ease international restrictions on the handling of dronabinol, the main active principle of cannabis, and its stereoisomers.
The FCC is considering whether to expand available radio frequency (RF) for implanted and body-worn wireless devices, but manufacturers disagree on whether additional RF is needed.
Although the American Association for Clinical Chemistry (AACC) supports a recent FDA guidance on informed consent for in vitro diagnostic (IVD) device clinical trials, the group says several guidance details remain unclear.
The FDA recently received comments on its "Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials -- Draft Guidance for Industry and FDA Staff," issued May 23.
An independent panel commissioned last summer to review Guidant's handling of its failed heart devices said the company should form an external committee of experts to serve as advisers.