Topic: Medical Devices

FDA panel backs implant for mild heart failure

FDA panel recommends Boston Scientific's electronic heart device for less-severe heart diseaseFederal health advisers said Thursday an electronic heart implant should be approved for a large group of heart-disease patients who currently aren't eligible for the device. A Food and Drug Administration panel of cardiologists voted unanimously in ...
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Boston Sci could resume ICD sales within 30 days

CHICAGO (Reuters) - Boston Scientific Corp. <BSX.N> could be selling implantable heart rhythm devices again within 30 days if no new issues arise beyond the paperwork problems revealed this week. "Our number one conclusion is ... that Boston likely overreacted in pulling its products from the market and has ...
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FDA critiques Medtronic's MRI-compatible pacemaker

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 ...
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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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