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French Company Gets FDA Breakthrough Status For Brain Device

 
• By Brian Bossetta

The US FDA has designated Carthera’s SonoCloud-9 as a breakthrough device. The French company’s ultrasound technology is designed to treat a wide range of brain diseases, including recurrent glioblastoma.

Doctor Holding Brain
• Source: Shutterstock

The Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has granted breakthrough designation to French device maker Carthera for its ultrasound therapy that treats an array of brain diseases, such as recurrent glioblastoma, an aggressive brain tumor.

Glioblastoma is the most common primary brain cancer, according to MD Anderson Cancer Center, with around 12,000 cases annually in the US.

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