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05Jul

FDA recall for The HeartWare Ventricular Assist Device (HVAD) by Medtronic, Inc.

The FDA has identified this as a Class I recall for The HeartWare Ventricular Assist Device (HVAD) by Medtronic, Inc., the recall is due to welding defects that allow separation of the two cell battery packs used to power the system. The welding defect may cause the battery to malfunction and no longer provide power or prevent the battery from holding a full charge or properly recharging. As a result, the battery may fail suddenly. If this malfunction occurs, it will trigger a Power Disconnect alarm on the controller screen and in the Alarm Log tab of the HVAD Monitor while the affected battery is still connected to the controller.

18Nov

GE Healthcare Receives FDA Clearance for First Artificial Intelligence (AI) Algorithm

GE Healthcare today announced it has received Food and Drug Administration (FDA) approval for an artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.0, an industry-first collection of AI algorithms embedded on a mobile x-ray device for automated measurements, case prioritization and quality control.

29Sep

FDA approves TransMedics’ OCS Heart system

  • FDA approves TransMedics OCS Heart system

TransMedics Group has secured approval from the US Food and Drug Administration (FDA) for its OCS Heart System that is developed for use with organs collected from donors after brain death (DBD).

The OCS Heart System is designed to preserve DBD donor hearts deemed unsuitable for procurement and transplantation at initial assessment due to limitations of prolonged cold static cardioplegic preservation.

28Sep

Emergency Reversal of Anticoagulation

  • Emergency Reversal of Anticoagulation

The risk of bleeding varies with the type of anticoagulant agent used. The incidence of bleeding while on warfarin has been estimated at 15-20% per year, with life-threatening bleeding occurring.
At a rate of 1-3% per year. Providers should remember that all patients with emergent or life-threatening bleeding require attention to basic interventions, including cessation of anticoagulation therapy, blood product transfusions, and assessment for airway protection.