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FDA

Latest Headlines

Latest Headlines

FDA mobile medical app guidance faces delay to 2013

  New congressional action proposed by Sen. Tom Harkin (D-Iowa) could seriously delay the Food and Drug Administration's mobile medical app guidance.

Reclassifying EHRs as medical devices would come at a cost

Just two weeks ago, I expressed concern that a cyber attack on unprotected medical devices can infect the electronic health records to which they are connected, causing the EHR to malfunction and the

Republicans push FDA, FCC for faster movement on mobile apps

Republican House members are pushing the Food and Drug Administration and Federal Communications Commission to smooth some of the regulatory bumps in the road for mobile medical apps, according to a

'Alarm fatigue' reduction efforts underway by FDA, Joint Commission

Desensitization to alarms on medical devices continues to be a problem for hospitals throughout the United States, so much so that both the Food and Drug Administration and The Joint Commission are

Dirty surgical tools a dangerous, growing problem

Blood, tissue and other debris from previous procedures sometimes remain on the surgical tools used on other patients. Even worse, the problem is growing, according to NBC News . Investigations at

MRC pushes for more time on FDA's mobile medical app guidance

In a bit of a surprise move, the mHealth Regulatory Coalition has asked the U.S. Food and Drug Administration to revamp and republish its proposed guidance for mobile medical apps --but as a second

FDA to create drug interaction alert app

The U.S. Food and Drug Administration is scouting for a vendor to create a new smartphone app to track adverse drug reactions to experimental medications, according to a notice released last week .

FDA experts share legal guidance on telehealth

Here's a terrific resource for telemedicine developers, courtesy of Washington, D.C.-based law firm Epstein Becker Green in Washington, D.C. Two months ago, the firm created a formal legal opinion

Carestream wins FDA approval for medical image viewing on tablets

Medical-imaging firm Carestream just received a clearance letter from the U.S. Food and Drug Administration for its Vue Motion medical imaging app for iPads and other tablets. With plenty of

Hospitals, vendors team to influence FDA, HHS on decision support

Responding to a recent focus on clinical decision support systems by the U.S. Food and Drug Administration and the Department of Health & Human Services, an industry coalition is forming to