WASHINGTON – The turbulence in the U.S. healthcare market has makers of devices and diagnostics scrambling for emerging markets, and the government of the United Mexican States sent a representative to AdvaMed 2011 to talk about recent regulatory developments in the world's 11th most populous nation. (Medical Device Daily)

Healthcare reform has as a million audiences, and it's interesting to see what some of them are reading about the Patient Protection and Affordable Care Act (ACA). Let's look at an opinion piece appearing recently in the New England Journal of Medicine penned by a trio including Michael Chernew, PhD, perhaps the most influential healthcare economist in Washington. Chernew and his co-authors remind that calculations of Medicare costs typically consists of a comparison of the world with and without the ACA, stating that the ACA has to do better than healthcare inflation of about 5.5% in order to impress the...

WASHINGTON – The Advanced Medical Technology Association (AdvaMed; Washington) held its policy briefing on the first day of AdvaMed 2011 and the association's representatives offered a quick look at what AdvaMed sees as its concerns over pressure on U.S. device makers, but AdvaMed's leadership indicated that the concern over Medicare imaging seems to be easing. (Medical Device Daily)

Much has been made of the slow-down in device approvals at FDA's Center for Devices and Radiological Health, and the explanations range from a preoccupation with scientific and statistical minutia to a paranoia that yet another incident will subject the agency to another lashing in the court of public opinion. But let's face it, FDA gets some pretty shabby treatment on Capitol Hill, too. I recall a hearing in which then-Senator Hillary Clinton (D-New York) grilled incoming FDA commissioner Andrew von Eschenbach, MD, like a common criminal. She and Sen. Patty Murray (D-Washington) never allowed von Eschenbach to completely answer...