Why BrioHealth’s Brio4Kids trial could become a test case for pediatric LVAD innovation
BrioHealth Solutions has received United States Food and Drug Administration conditional approval to initiate the Brio4Kids Trial, a pediatric clinical evaluation of the BrioVAD System in children with advanced heart failure. The trial will proceed under the existing Investigational Device Exemption for the INNOVATE Trial, giving the medical device developer a defined pathway to test […]