FDA Review of Radiologic AI Algorithms: Process and Challenges.
Journal:
Radiology
Published Date:
Jan 1, 2024
Abstract
A Food and Drug Administration (FDA)-cleared artificial intelligence (AI) algorithm misdiagnosed a finding as an intracranial hemorrhage in a patient, who was finally diagnosed with an ischemic stroke. This scenario highlights a notable failure mode of AI tools, emphasizing the importance of human-machine interaction. In this report, the authors summarize the review processes by the FDA for software as a medical device and the unique regulatory designs for radiologic AI/machine learning algorithms to ensure their safety in clinical practice. Then the challenges in maximizing the efficacy of these tools posed by their clinical implementation are discussed.