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AI medical devices cleared by FDA: 1,000+ in 2024, 75% radiology second opinions, few trials

Year: 2026

Type: preprint

Abstract: FDA cleared over 1,000 AI medical devices by 2024, with 75% in radiology for second opinions and triage, mostly validated by retrospective studies, not trials. Independent technical note mirroring the canonical version: https://secondopinionfromai.com/blog/ai-medical-devices-cleared-by-fda-1000-in-2024-75-radiology-second-opinions-few-trials.php

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.23387153

Author: Chapman, Avery

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: green

OpenAlex ID: W7221972653

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