June 19, 2013 | Vol. 10 No. 120
Industry’s case against significant reforms to the FDA’s policy on when devicemakers must submit a new 510(k), made during a Thursday public meeting, drew pushback from consumer groups that argued current controls don’t ensure patient safety.
The China Food and Drug Administration last month released a document outlining acceptance criteria for in vitro diagnostic reagents makers.
A medical expert argues that the Trans-Pacific Partnership contains little language about actual trade issues and more language promoting American corporate interests such as evergreening and deregulation.
A study published this month showed that patients widely support medical imaging for the diagnosis of illness.
Boston Scientific Begins Patient Enrollment in U.S. Clinical Trial for Use of Vercise DBS System for Parkinson's Disease
Boston Scientific has enrolled its first patients in a U.S. trial of its Vercise deep brain stimulation device.
Delcath is being sued by investors after a negative FDA vote.
The Department of Homeland Security and the FDA have discovered that nearly 300 medical devices from 40 companies have password security problems.
A June article in the journal Circulation shows that overall health level may be a more important predictor of success with an implanted defibrillator than age.
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