US Epilepsy Devices Market: Navigating the Complex Regulatory...

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2025-12-09 12:13:17 - Traduire

US Epilepsy Devices Market: Navigating the Complex Regulatory Landscape and Approvals for New Technology.

The FDA's Rigorous Approval Pathway for Implantable Devices The US Food and Drug Administration (FDA) maintains a rigorous, multi-stage approval process for neurological devices, particularly those that are surgically implanted or involve proprietary algorithms. Manufacturers typically follow the Pre-Market Approval (PMA) pathway for novel, high-risk devices like RNS and DBS, necessitating...

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