Medical Devices Today

“Ordered, Intimidated And Coerced”? CDRH Targeted In Misconduct Probe

Full article reprinted from "The Gray Sheet" - November 24, 2008

Find out how FDA's device center has until Dec. 1 to respond to a Congressional inquiry into allegations of wrongdoing in its pre-market review process.

FDA Panel Success Puts ThermoCool First In Line For AF Ablation Indication

Full article reprinted from "The Gray Sheet" - November 24, 2008

Find out how Johnson & Johnson/Biosense Webster's Navistar ThermoCool saline irrigated radio-frequency ablation catheterhas the inside track to become the first ablation catheter with an FDA-approved indication for atrial fibrillation following a unanimous recommendation from the agency's Circulatory System Devices Panel.

FDA Previews Final Drug-Eluting Stent Guidance

Full article reprinted from "The Gray Sheet" - October 20, 2008

FDA previewed several changes it will make in its final drug-eluting stent guidance at the Transcatheter Cardiovascular Therapeutics symposium in Washington, D.C., on Oct. 15.

Obama Wants Comparative Effectiveness Institute; Is NICE A Good Model?

Full article reprinted from "The Gray Sheet" - October 20, 2008

Democratic presidential candidate Sen. Barack Obama has proposed a comparative effectiveness institute as part of his health care reform plan, but an independent analysis by the Lewin Group suggests that many physicians may not adopt the practices recommended by such a body.