Claria Medical secures FDA De Novo classification for hysterectomy device
Regulatory submission for the device was supported by a multinational, prospective, controlled clinical study.
14 July 2026
14 July 2026
Regulatory submission for the device was supported by a multinational, prospective, controlled clinical study.
The open-label trial enrolled patients aged between two and 12 years who have a clinical diagnosis of Dravet syndrome.
Cellares will adapt and automate the SBT-77-7101 manufacturing process from Sonoma for use with Cell Shuttle.
The collaboration initially focuses on tuberculosis research in Thailand, where Fosun has identified customer interest.
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