FDA approval for human trials means the US Food and Drug Administration has cleared a device for testing in people.
Neuralink received an Investigational Device Exemption (IDE), the FDA permission to test an unapproved device in a trial, in May 2023 and opened PRIME recruitment that September (Neura Pod). An IDE is different from approval for sale, which no Neuralink device has yet. Internal projections reported by Bloomberg in July 2025 aimed for Telepathy approval in 2029.
