Topic: Medical Technology

FDA questions new use for Boston Science device

The Food and Drug Administration said Tuesday a heart device from Boston Scientific appears effective for a new group of patients, though questions remain about the accuracy of the company's study of the device. Boston Scientific has asked the FDA to approve its heart rhythm device to treat mild ...
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Boston Scientific suspends defibrillator sales

Medical device maker Boston Scientific said Monday it is suspending sales of its heart-shocking defibrillator implants after failing to alert regulators to changes in manufacturing of the best-selling devices. The company said it uncovered two production changes that were not cleared with the Food and Drug Administration. Medical device makers ...
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Boston Scientific suspends ICD sales, shares slump

CHICAGO (Reuters) - Boston Scientific Corp suspended sales of its implantable heart defibrillators on Monday after failing to notify regulators of changes in how it manufactures the devices, sending shares down as much as 19 percent to a one-year low. Boston Scientific said it had voluntarily stopped shipments and was retrieving ...
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Boston Scientific Suspension

Boston Scientific Suspension
In this undated product image provided by Boston Scientific, a "Cognis" heart defibrillator implant is shown. The medical device maker on Monday, March 15, 2010 said it is suspending sales of its heart-shocking defibrillator implants after uncovering a documentation error with the manufacture of the top-selling devices. (AP Photo/Boston ...
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