Why this market is moving now
- The FDA authorized 92 AI-enabled devices in Q1 2026 and 89 in Q2 2026.
- The FDA's cumulative list passed 1,600 devices by September 2026.
Key figures
Each figure names the source it came from. Open the source list below to read the quoted line.
| Figure | Value | Year | Source |
|---|---|---|---|
| The FDA has authorized over 1,600 AI-enabled medical devices for marketing in the United States as of September 2026. | 1,600+ devices | 2026 | U.S. Food and Drug Administration |
| The FDA's AI-enabled device list counted 1,614 authorized devices through June 2026. | 1,614 devices | 2026 | The Imaging Wire |
| Radiology accounts for 1,230 of the FDA-authorized AI-enabled devices through June 2026, or 76%. | 1,230 devices | 2026 | The Imaging Wire |
| The FDA's list counted 1,451 AI-enabled devices through the end of 2025, 1,104 of them in radiology. | 1,451 devices | 2025 | The Imaging Wire |
| The FDA authorized 89 AI-enabled devices in the second quarter of 2026 and 92 in the first quarter, with radiology making up 66 of the Q2 devices. | 89 devices (Q2 2026) | 2026 | The Imaging Wire |
| GE HealthCare has 134 FDA-authorized AI-enabled devices, the most of any vendor; Siemens Healthineers has 101 and Philips 62 (counts include acquired companies). | 134 devices (GE HealthCare) | 2026 | The Imaging Wire |
| Radiology's share of AI-enabled device authorizations was 80% in 2023, 73% in 2024 and 75% for all of 2025. | 75 % radiology share of 2025 authorizations | 2025 | The Imaging Wire |
Sources and method
The figures on this page come from the public sources listed below. Read how we work.
- U.S. Food and Drug Administration: Artificial Intelligence-Enabled Medical Devices (2026-09-22)
Quoted lines
- Figure 1
The FDA has authorized over 1,600 AI-enabled medical devices for marketing in the United States as of September 2026.
- Figure 1
- The Imaging Wire: Top 10 AI Vendors by FDA Approvals (2026-09-14)
Quoted lines
- Figure 2
Authorized 1,614 AI-enabled medical devices since it started keeping track
- Figure 3
Authorized 1,230 radiology devices, or 76% of all AI-enabled medical authorizations.
- Figure 5
In the second quarter of 2026, the FDA authorized 89 AI-enabled medical devices, slightly fewer than the 92 devices it authorized
- Figure 6
GE HealthCare: 134
- Figure 2
- The Imaging Wire: FDA Updates AI List with New Clearances (2026-03-12)
Quoted lines
- Figure 4
Authorized 1,451 AI-enabled medical devices since it began keeping track in 1995.
- Figure 7
For all of 2025, radiology secured 75% of authorizations, compared to 73% for all of 2024 and 80% for 2023.
- Figure 4
Companies to watch
GE HealthCare
Holds the most FDA-listed AI-enabled devices, 134 (includes acquired companies).
Siemens Healthineers
Second by FDA-listed AI-enabled devices, with 101.
Philips
Third by FDA-listed AI-enabled devices, with 62.
What the full report covers
- 01Executive summary
The answer in one page: size, direction and what moves it - 02Market definition and scope
What is in and out of the United States market - 03Market size, 2021 to 2025
Historical series and growth rates - 04Outlook to 2031
Base, low and high scenarios with stated assumptions - 05Rules, policy and deadlines
Regulation and programmes that change demand - 06Drivers and barriers
What accelerates or slows adoption, by customer segment - 07Prices, costs and margins
Unit economics where public data allows - 08Competitive landscape
8 to 12 company profiles with recent moves - 09Opportunities and risks
For new entrants, suppliers and investors - 10Method and sources
Every assumption and source, listed
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Frequently asked questions
How many AI medical devices has the FDA authorized?
The FDA says it has authorized over 1,600 AI-enabled medical devices as of September 2026. The Imaging Wire's read of the list counts 1,614 through June 2026.
How many of them are for radiology?
The Imaging Wire counts 1,230 radiology devices, or 76% of all AI-enabled authorizations, through June 2026.
Who has the most FDA-authorized AI imaging devices?
GE HealthCare has 134, followed by Siemens Healthineers with 101 and Philips with 62, per The Imaging Wire's analysis of the FDA list. Counts include acquired companies.
How fast are new AI devices being authorized?
The FDA authorized 92 AI-enabled devices in Q1 2026 and 89 in Q2 2026, with radiology making up 66 of the Q2 devices.
What was the count at the end of 2025?
The Imaging Wire reported 1,451 AI-enabled devices on the FDA list through the end of 2025, including 1,104 in radiology.
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