FDA Announcements Section

The FDA, on December 16, identified the recall by Getinge/Datascope/Maquet of its Cardiosave Hybrid and Cardiosave Rescue Intra-Aortic Balloon Pumps (IABPs) as Class I, the most serious.

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.

The FDA has identified this as a Class I recall on Datascope/Getinge/Maquet for Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump Battery Packs due to the risk of the battery failing and having a shortened run-time due to substandard batteries not meeting perform

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.

The US Food and Drug Administration has approved the Portico with FlexNav (Abbott) transcatheter aortic valve replacement (TAVR) system for patients with "symptomatic, severe aortic stenosis who are at high or extreme risk for open-heart surgery," the company announced recently.

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.