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FDA grants breakthrough nod for Carthera’s SonoCloud-9

June 22, 2022 By Sean Whooley

Carthera SonoCloud
[Image from Carthera’s website]
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).

Get the full story at our sister site, MassDevice.

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance Tagged With: Carthera, FDA

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