The FDA Landscape for AI Medical Devices: Trends and Regulatory Pathways Through 2025

Discover the growth and FDA regulatory pathways of AI medical devices through 2025, including 510(k), De Novo, and PMA approvals essential for clinical use.

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Publication Details

Journal
Zenodo (CERN European Organization for Nuclear Research)
Published
2025-05-24
DOI
https://doi.org/10.5281/zenodo.17996447
Primary Topic
Artificial Intelligence in Healthcare and Education
Type
article
Field-Weighted Citation Impact
0.00
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article

The FDA Landscape for AI Medical Devices: Trends and Regulatory Pathways Through 2025

Raşit Dinç
Zenodo (CERN European Organization for Nuclear Research)
Artificial Intelligence in Healthcare and Education
article

The FDA Landscape for AI Medical Devices: Trends and Regulatory Pathways Through 2025

Raşit Dinç
article en

Abstract

Discover the growth and FDA regulatory pathways of AI medical devices through 2025, including 510(k), De Novo, and PMA approvals essential for clinical use.

Zenodo (CERN European Organization for Nuclear Research)
Design Intelligence (United States) (US)
Openalex Percentile: Top 41%
Artificial Intelligence in Healthcare and Education
DOIOpen Access PDFOpenAlex
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The FDA Landscape for AI Medical Devices: Trends and Regulatory Pathways Through 2025 — Raşit Dinç · Zenodo (CERN European Organization for Nuclear Research) (2025) | TGRS Research Map | TGRS