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AdvaMed

Latest Headlines

Latest Headlines

Devicemakers eye outsourcing to limit hit from Obama tax

The medical device industry has waged war on a new tax on device makers as part of Obama's healthcare reform, and companies have begun talking up plans to outsource manufacturing work overseas as a result of the tax.

Device industry, FDA ink $595M user-fee deal

After more than a year of negotiations, medical device industry groups have tentatively agreed to a new 5-year, $595 million user-fee agreement with FDA--about double the old deal. Congress must sign

IOM report fuels debate over device reviews

Dump the 510(k) process. At the end of the day, that was the Institute of Medicine's (IOM) advice to the FDA in its much-anticipated report Friday. The nonprofit group, tasked by the FDA to generate

Ubl, MacMillan present 'Competitiveness Agenda' for med tech

The U.S. faces the loss of its leadership in medical technology if policymakers don't move to level the playing field between it and other countries, according to Stephen Ubl, president and CEO of

Device groups sign global compliance pact

Leaders from nine medical technology associations have joined together to sign " Global Compliance Statement on Interactions Between Medical Technology Companies and Healthcare Professionals (HCPs) ,"

Assisting the wounded warrior

WASHINGTON, D.C. - The military of today differs tremendously from the past, not only in combat styles, but also in its quest to rehabilitate and reactivate wounded veterans in its volunteer

AdvaMed urges FDA to make minor 510(k) changes

The Advanced Medical Technology Association is urging the FDA to move forward with changes to the premarket review program for low- and moderate-risk medical devices "in a way that builds on the