News tagged with fda

FDA approves expanded indication for CRT devices

(HealthDay)—The U.S. Food and Drug Administration has approved an application from Medtronic for revised labeling for two cardiac resynchronization pacemakers (CRT-P) and eight cardiac resynchronization ...

Apr 15, 2014
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FDA reviews DNA-based colon cancer screening kits

The Food and Drug Administration is weighing the benefits and risks of two experimental colon cancer screening tests which use DNA from a patient's stool to detect dangerous tumors and growths.

Mar 24, 2014
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Implanted hearing device approved

(HealthDay)—The first implantable device for adults with a severe or profound form of a condition called "sensorineural hearing loss" has been approved by the U.S. Food and Drug Administration.

Mar 20, 2014
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Sen. Joe Manchin seeks to block new painkiller

U.S. Sen. Joe Manchin is calling on the government's top health official to overturn the approval of a powerful painkiller, arguing that the pill Zohydro could add to the national epidemic of prescription drug abuse.

Mar 11, 2014
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Study examines gap in federal oversight of clinical trials

An analysis of nearly 24,000 active human research clinical trials found that between 5 percent and 16 percent fall into a regulatory gap and are not covered by two major federal regulations, according to a study in the March ...

Mar 04, 2014
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