Analysis of Devices Authorized by the FDA for Clinical Decision Support in Critical Care.
作者信息
Lee Jessica T, Moffett Alexander T, Maliha George, Faraji Zahra, Kanter Genevieve P, Weissman Gary E
机构信息
Palliative and Advanced Illness Research Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
Division of Pulmonary, Allergy, and Critical Care, Department of Medicine, Perelman School of Medicine, University of Pennsylvania, Philadelphia.
出版信息
JAMA Intern Med. 2023 Dec 1;183(12):1399-1401. doi: 10.1001/jamainternmed.2023.5002.
Abstract
摘要
相似文献
1
Analysis of Devices Authorized by the FDA for Clinical Decision Support in Critical Care.美国食品药品监督管理局批准用于重症监护临床决策支持的设备分析
JAMA Intern Med. 2023 Dec 1;183(12):1399-1401. doi: 10.1001/jamainternmed.2023.5002.
2
Pharmaceuticals and Medical Devices: FDA Oversight.药品和医疗器械：美国食品药品监督管理局监管
Issue Brief Health Policy Track Serv. 2018 Dec 24;2018:1-42.
3
Marketing and US Food and Drug Administration Clearance of Artificial Intelligence and Machine Learning Enabled Software in and as Medical Devices: A Systematic Review.营销与美国食品和药物管理局对人工智能和机器学习在医疗器械中的应用和授权软件的审批：系统评价。
JAMA Netw Open. 2023 Jul 3;6(7):e2321792. doi: 10.1001/jamanetworkopen.2023.21792.
4
FDA backs clinician-free AI imaging diagnostic tools.美国食品药品监督管理局支持无需临床医生参与的人工智能影像诊断工具。
Nat Biotechnol. 2018 Aug 6;36(8):673-674. doi: 10.1038/nbt0818-673a.
5
FDA Regulation of Laboratory Clinical Decision Support Software: Is It a Medical Device?美国食品药品监督管理局对实验室临床决策支持软件的监管：它是一种医疗器械吗？
Clin Chem. 2023 Apr 3;69(4):327-329. doi: 10.1093/clinchem/hvad011.
6
Generalizability of FDA-Approved AI-Enabled Medical Devices for Clinical Use.美国食品药品监督管理局（FDA）批准的用于临床的人工智能医疗设备的可推广性。
JAMA Netw Open. 2025 Apr 1;8(4):e258052. doi: 10.1001/jamanetworkopen.2025.8052.
7
Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions.来自食品和药物管理局的相互矛盾的信息：错失了引领安全有效的医疗人工智能解决方案标准的机会。
J Am Med Inform Assoc. 2021 Jun 12;28(6):1353-1355. doi: 10.1093/jamia/ocab035.
8
Medical Devices Applying for Outpatient Medicare Supplemental Payments.申请门诊 Medicare 补充支付的医疗器械。
JAMA Health Forum. 2024 Nov 1;5(11):e244016. doi: 10.1001/jamahealthforum.2024.4016.
9
Regulatory and legal implications of modifying FDA-approved medical devices.修改美国食品药品监督管理局（FDA）批准的医疗器械的监管及法律影响。
J Vasc Interv Radiol. 2000 Jan;11(1):19-23. doi: 10.1016/s1051-0443(07)61272-x.
10
FDA Perspective on the Regulation of Artificial Intelligence in Health Care and Biomedicine.美国食品药品监督管理局对医疗保健和生物医学领域人工智能监管的看法。
JAMA. 2025 Jan 21;333(3):241-247. doi: 10.1001/jama.2024.21451.
引用本文的文献
1
Unregulated large language models produce medical device-like output.不受监管的大语言模型会生成类似医疗设备的输出。
NPJ Digit Med. 2025 Mar 7;8(1):148. doi: 10.1038/s41746-025-01544-y.
2
Introducing the Team Card: Enhancing governance for medical Artificial Intelligence (AI) systems in the age of complexity.推出团队卡片：在复杂时代加强对医学人工智能（AI）系统的治理。
PLOS Digit Health. 2025 Mar 4;4(3):e0000495. doi: 10.1371/journal.pdig.0000495. eCollection 2025 Mar.
3
Evaluating and addressing demographic disparities in medical large language models: a systematic review.评估和解决医学大语言模型中的人口统计学差异：一项系统综述。
Int J Equity Health. 2025 Feb 26;24(1):57. doi: 10.1186/s12939-025-02419-0.
4
Evaluation and Regulation of Artificial Intelligence Medical Devices for Clinical Decision Support.用于临床决策支持的人工智能医疗设备的评估与监管
Annu Rev Biomed Data Sci. 2025 Aug;8(1):81-99. doi: 10.1146/annurev-biodatasci-103123-095824. Epub 2025 Feb 19.
5
Lessons for local oversight of AI in medicine from the regulation of clinical laboratory testing.临床实验室检测监管为医学人工智能的本地监督提供的经验教训。
NPJ Digit Med. 2024 Dec 13;7(1):359. doi: 10.1038/s41746-024-01369-1.
6
Early Warning Scores With and Without Artificial Intelligence.早期预警评分与人工智能。
JAMA Netw Open. 2024 Oct 1;7(10):e2438986. doi: 10.1001/jamanetworkopen.2024.38986.
7
Large language model non-compliance with FDA guidance for clinical decision support devices.大型语言模型不符合美国食品药品监督管理局关于临床决策支持设备的指南。
Res Sq. 2024 Sep 9:rs.3.rs-4868925. doi: 10.21203/rs.3.rs-4868925/v1.
8
The testing of AI in medicine is a mess. Here's how it should be done.人工智能在医学领域的测试一团糟。以下是正确的做法。
Nature. 2024 Aug;632(8026):722-724. doi: 10.1038/d41586-024-02675-0.
9
Artificial intelligence in pharmacovigilance - Opportunities and challenges.药物警戒中的人工智能——机遇与挑战。
Perspect Clin Res. 2024 Jul-Sep;15(3):116-121. doi: 10.4103/picr.picr_290_23. Epub 2024 Mar 27.
10
[Artificial intelligence in intensive care medicine].[重症医学中的人工智能]
Med Klin Intensivmed Notfmed. 2024 Apr;119(3):189-198. doi: 10.1007/s00063-024-01117-z. Epub 2024 Mar 28.
Zotero 插件