medicaldevices
A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced Monday. Related Article Patients Facing Death Are Opting for a Lifesaving Heart Device — But at What Risk? The HeartMate 3 is considered the safest mechanical heart pump of its kind, but a federal database contains more than 4,500 reports in which the medical device may have caused or contributed to a patient’s death. Read More The recall comes years after surgeons say they first noticed problems with the HeartMate II and HeartMate 3, manufactured by Th...
Kaiser Health News
When the FDA recently convened a committee of advisers to assess a cardiac device made by Abbott, the agency didn’t disclose that most of them had received payments from the company or conducted research it had funded — information readily available in a federal database. One member of the FDA advisory committee was linked to hundreds of payments from Abbott totaling almost $200,000, according to a database maintained by the Department of Health and Human Services. Another was connected to 100 payments totaling about $100,000 and conducted research supported by about $50,000 from Abbott. A thi...
Kaiser Health News
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