Carthera announced today that it received FDA breakthrough device designation for its SonoCloud-9 system.
Paris-based Carthera designed SonoCloud-9 for implantation in a skull window below the skin. Once in place, the device becomes invisible. When activated for a few minutes using a transdermal needle connected to an external control unit, it uses low-intensity pulsed ultrasound to temporarily disrupt the blood-brain barrier (BBB).