The world's first all-magnetic levitation artificial heart for children clinical trial by SynCardia received approval from the FDA in the United States.

Concentric Medical, a wholly-owned subsidiary of BrioHealth Solutions in the United States, announced that the company has received conditional approval from the US Food and Drug Administration to initiate clinical evaluation of the BrioVAD system for pediatric patients with advanced heart failure. The Brio4Kids trial, as an extension of the INNOVATE trial to the pediatric field, will rely on the latter's research instrument exemption. This not only marks the first prospective clinical trial of a fully magnetically levitated artificial heart for pediatrics, but also the first time the same left ventricular assist device is being concurrently evaluated in adult and pediatric populations, filling a gap in the treatment of pediatric heart failure.