HeartMate VAD Controller Recalled After 26 Deaths
Abbott is issuing hardware and software updates in an attempt to resolve an issue in which patients risk injury or death when attempting to switch to a backup controller for HeartMate II left-ventricular assist devices at home.
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Fresh-off bringing Thoratec Corp. into the fold, St. Jude Medical Inc. says its new left-ventricular-assist device unit has met a major regulatory milestone on schedule.
The templates from the US agency provide guidance to manufacturers developing antibody tests for clinical or at-home use.
Already cleared to monitor the viral load in HIV-positive individuals, the test has now been approved for initial diagnosis as well.