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Premarket Approval

Premarket Approval (PMA) is a regulatory pathway for novel, high-risk medical devices, including implanted brain-computer interfaces.

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Jan 31, 2026
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What are the FDA’s standards and recent oversight actions regarding invasive brain‑computer interface devices?

The regulates implanted brain‑computer interfaces (iBCIs) as medical devices and applies established device pathways and device‑specific guidance to them, including a 2021 final guidance on implanted ...

Jan 13, 2026

Which regulatory bodies have evaluated neurodefender and is it FDA-approved?

The documents supplied describe how the U.S. Food and Drug Administration regulates neuromodulation and neurological devices—outlining pathways such as 510(k), De Novo, Premarket Approval (PMA), Human...