Title: 

University of Pennsylvania Startup Sonura Care Updates on Gathering Evidence & FDA Classification

Summary:
Sonura Care Inc. provides auditory protection & parental connection for hospitalized newborns. The device, the Sonura Beanie, replicates the auditory environment of the womb to promote healthier growth and development for newborns. Sonura was founded by a pair of bioengineering undergraduates at the University of Pennsylvania and is based in Philadelphia. In this presentation, the team will share next steps for gathering evidence to improve care quality and for navigating ongoing classification discussions with the FDA.