Tag Archives: FDA Device Approval

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Demystifying Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices

By Cory Hayes, Jeanna Blitz
Artificial Intelligence Graphic

Several alternatives exist to obtain FDA approval of artificial intelligence-enabled medical technology. Determining the best approach for a new device will require an awareness of each pathway’s specific requirements. An appreciation of the unique considerations for artificial intelligence-enabled technologies is another essential component of an efficient and effective application.

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