humanitarian device exemption Archives - NeuroNews International

Serenity gains “landmark” US FDA humanitarian device exemption for novel cerebral...

31 March 2026

Serenity Medical, a NeuroTechnology Investors (NTI) portfolio company, has today announced a “landmark” US Food and Drug Administration (FDA) humanitarian device exemption (HDE) approval for its novel...

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Serenity gains “landmark” US FDA humanitarian device exemption for novel cerebral...