FDA updates its list with 56 new AI-powered radiology devices, bringing the total to over 1,000 approved tools.
Key Details
- 1FDA list updated in early December to include over 1,300 AI-enabled medical devices.
- 2Radiology remains the dominant application, with 1,039 out of total devices approved.
- 356 new radiology-specific AI devices added between mid-July and September.
- 4Nearly 80% of all FDA-cleared AI medical tools are for radiology.
- 5Major companies such as GE HealthCare, Siemens, Fujifilm, Qure.ai, and DeepHealth featured among the approvals.
- 6The number of approvals has surged from 500 at the start of 2023 to over 1,300 by year's end.
Why It Matters
This rapid expansion in FDA-approved AI devices underscores radiology’s central role in clinical imaging innovation and regulatory acceptance. Widespread adoption can further transform workflows, diagnostics, and care standards across medical imaging.
Source
Radiology Business
Related News
•HealthExec
Mayo Clinic Sued Over Alleged AI Improprieties and Whistleblower Retaliation
A former Mayo Clinic research director sues the institution, alleging retaliation after raising concerns about improper AI use affecting patient safety and data integrity.
•Radiology Business
Majority of Patients Want Disclosure When AI Used in Imaging
A new survey finds that nearly all patients want to be informed when AI is utilized in medical imaging interpretation.
•Radiology Business
Radiology Dominates FDA AI Algorithm Clearances in 2026
Radiology accounted for 68 new FDA-cleared AI algorithms in early 2026, making up more than three-quarters of all AI clinical clearances.