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Floreo Files FDA De Novo Request for FloreoRx, the First VR Autism Therapy Seeking FDA Authorization

Floreo Files FDA De Novo Request for FloreoRx, the First VR Autism Therapy Seeking FDA Authorization

by Ethan Webb | Apr 27, 2026 | Regulation, Technology

Key Takeaways Floreo filed a De Novo request, not a 510(k), which would create a new FDA device classification. The De Novo pathway is reserved for novel devices with no legally marketed predicate, meaning an FDA grant would establish FloreoRx as the first predicate...

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