FDA rejects Medtronic heart monitor |
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Published
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Thu, 01 Mar 2007 23:46
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WASHINGTON (AP) - Federal health advisers recommended Thursday that the government not approve a novel implantable device designed to detect worsening heart failure.The recommendation to the Food and Drug Administration against the Chronicle Implantable Hemodynamic Monitor came on a 9-2 vote. The FDA isn't required to follow its advisory committees' advice, but it does so most of the time.A study of the device, made by Medtronic Inc., suggested it isn't effective.The Minneapolis-based company's device works by taking heart rate, temperature, pressure and patient activity measurements. The data can be downloaded by doctors in the office or securely transmitted to the Web for viewing.Medtronic is studying a defibrillator that incorporates the monitoring technology.Copyright 2007 Associated Press. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
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Medtronic heart devices gets FDA review 