FDA approves sale of 4,000 heart devices
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A Massachusetts company received federal approval Tuesday to sell up to 4,000 artificial hearts a year, though the number of devices implanted annually will likely be far smaller.
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The Food and Drug Administration approved an implantable computer chip that can pass a patient's medical details to doctors.
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Defibrillators, stents, artificial knees and hips will be among the gadgets more closely tracked under the new rules.
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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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A key Medicare coverage decision, expected as early as Wednesday afternoon, could vastly expand the &#36;4.8 billion market for devices used to resuscitate patients whose hearts are beating out of control, doctors and device maker Medtronic Inc. said on Tuesday.
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NEWARK, New Jersey  - Four medical device implant makers will pay about $311 million and agree to federal monitoring and other reforms to settle a government probe into improper consulting contracts with surgeons, federal prosecutors said on Thursday.
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Devices made of heart tissue could screen drugs and power implantable robots.
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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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The U.S. Food and Drug Administration on Thursday approved a medical device maker's request to sell at-home heart defibrillators without a prescription.
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The US Food and Drug Administration has given clearance to Boston Scientific Corp. to market its Peripheral Cutting Balloon microsurgical dilation device in the United States.
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Tablets containing a combination of the blood pressure medication aliskiren and water pill hydrochlorothiazide have been approved by the Food and Drug Administration
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The U.S. Food and Drug  Administration on Thursday approved a medical device maker's  request to sell at-home heart defibrillators without a  prescription.
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The U.S. government on Tuesday  proposed expanding Medicare coverage for costly, potentially  life-saving implanted heart devices, a decision expected to  benefit makers Guidant Corp., Medtronic Inc. and St. Jude  Medical Inc.
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The implantable device won U.S. approval Monday for use as a temporary measure to keep alive patients on the verge of death while they wait for transplants.
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Medicare said it will soon fund implantable heart devices for thousands more patients, after publication of a landmark study finding the devices can save more lives, top agency officials said in a medical journal on Wednesday.
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A key Medicare coverage decision,  expected as early as Wednesday afternoon, could vastly expand  the $4.8 billion market for devices used to resuscitate  patients whose hearts are beating out of control, doctors and  device maker Medtronic Inc. said on Tuesday.
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A patient in the US is the first in the country to receive a implant device that automatically detects early symptoms of congestive heart failure.