AI in Healthcare: FDA-Approved AI Medical Devices and Adoption
How AI is entering medicine: FDA approvals of AI-enabled medical devices rose from 6 in 2015 to 223 in 2023, per the Stanford AI Index 2025.
- Updated October 1, 2026
- 3 min read
- 1 source
- Global
Executive Summary
The US Food and Drug Administration approved 223 AI-enabled medical devices in 2023, up from just six in 2015, according to Stanford's AI Index 2025. The index describes AI as moving from the lab into daily life, with healthcare among the leading areas. This report will expand to cover cumulative FDA device counts and WHO guidance as further primary data is verified.
Key Numbers
Charts
Annual approvals in the United States, as reported by Stanford AI Index 2025.
- 20156
- 2023223
Overview
This report tracks how AI is being approved and used in medicine. Regulatory approvals of AI-enabled medical devices are the clearest measurable signal so far.
The US FDA approved 223 AI-enabled medical devices in 2023, up from just six in 2015, according to Stanford's AI Index 2025 [1]. That is about 37 times as many approvals in a single year (FREEE.REPORT calculation).
Trends
Stanford's AI Index describes AI moving rapidly from the lab into daily life, citing healthcare and transportation as examples [1]. Its Science and Medicine chapter covers AI-driven trends in medicine [1]. AI work on protein folding was recognised with a Nobel Prize in chemistry, which the index lists as a sign of AI's impact on science [1].
Methodology
Device counts are annual FDA approvals of AI-enabled medical devices as reported by Stanford HAI's AI Index 2025, drawing on FDA data. They cover the United States only and are annual approvals, not cumulative totals. FREEE.REPORT calculation: 223 / 6 = about 37. WHO guidance and the FDA's full AI-enabled device list are not yet incorporated.
Sources
- [1]
The 2025 AI Index Report / Stanford HAI / 2025 / Accessed October 1, 2026 / View source
Figures are reproduced from the publishers above. Calculations marked as our own are derived from these figures. Always check the original source before using a number.
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