Work

FDA Approval of Artificial Intelligence and Machine Learning Devices in Radiology

Year: 2025

Type: article

Abstract: This sytematic review examines US Food and Drug Administration (FDA) premarket clearances for artificial intelligence and machine learning devices in radiology with emphasis on testing.

Source: JAMA Network Open

DOI: 10.1001/jamanetworkopen.2025.42338

Authors: Ram Sivakumar, Brian Lue, Shinjini Kundu

Institutions: Washington University in St. Louis, University of California, San Francisco

Language: English

Topic: Artificial Intelligence in Healthcare and Education

Subfield: Health Informatics

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,000

OpenAlex ID: W4416008635

FWCI: 8.323

Cites: 3

Cited by: 41

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