FDA Clears 1st Over-the-Counter Defibrillator
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Sept. 16, 2004 -- The power to shock an ailing heart back into motion may now be purchased without a doctor&#39;s prescription. Today the FDA approved the first over-the-counter sale of an automated external defibrillator (AED).
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WASHINGTON Oct. 13, 2004 - The Food and Drug Administration on Wednesday approved an implantable computer chip that can pass a patient&#39;s medical details to doctors, speeding care.
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When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies."
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People worried about sudden cardiac arrest no longer need a doctor's prescription to buy devices that jump-start the heart.     The Food and Drug Administration for the first time agreed Thursday to let consumers go online and purchase the $2,000 devices for home use...
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Heart attack prevention has just taken another step with the US Food and Drug Administration&#39;s go-ahead for one of the nation&#39;s best-selling cholesterol
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A computerized pill box that patients can keep at home to dole out their drugs on schedule and in the correct doses received federal approval Thursday.
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The first implantable treatment to  prevent sleep apnea has received approval from U.S. regulators,  the company that developed the procedure said Tuesday.
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Oct. 27, 2004 -- The US FDA has approved the first artificial disc for the treatment of severe low back pain, the device&#39;s manufacturer reports.
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Cardiovascular device maker Guidant Corp. (GDT.N: Quote, Profile, Research) said on Wednesday US regulators cleared the use of its implantable heart failure therapies for a wider group of patients.
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The US Food and Drug Administration (FDA) today approved FOSRENOL(R) (lanthanum carbonate), a new non-calcium, non-aluminium phosphate binder that reduces high serum phosphate levels in patients with end-stage renal disease (ESRD).
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A two-drug combination pill dramatically reduced deaths among blacks with heart failure, a landmark finding that is expected to lead to government approval of the first medication marketed for a specific race.
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U.S. regulators have approved a new  medical device to evaluate patients suspected of having blood  clots blocking vessels, including pulmonary arteries, the  manufacturer, Biosite Inc., said on Thursday.
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THURSDAY, June 21 (HealthDay News) -- A programmable device that allows professional caregivers to monitor how patients dispense their medications has been approved by the U.S. Food and Drug Administration, the agency said Thursday.
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WASHINGTON -- The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.
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Medtronic Inc. MDT.N on Monday said  U.S. regulators approved its Insync Sentry implantable  defibrillator (ICD) months earlier than it expected.
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uidant received approval yesterday from the Food and Drug Administration to sell stents that are inserted into the main neck artery to reduce the risk of strokes, making the company the
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The first new leukemia treatment in more than a decade approved specifically for use in children has been cleared by the Food and Drug Administration.