Topic: Medical Technology
FDA critiques Medtronic's MRI-compatible pacemaker
AP Features
The Food and Drug Administration voiced several complaints Tuesday with Medtronic's study of a new pacemaker that can be used in an MRI machine. Patients with pacemakers are generally discouraged from having MRI scans because the radio waves could interfere with the functioning of their device. Medtronic has asked ...
FDA questions new use for Boston Science device
AP Features
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 ...
Boston Scientific suspends defibrillator sales
AP Features
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 ...
Boston Scientific suspends ICD sales, shares slump
Reuters US Online Report Health News
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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