1995年即通过首款AI医疗器械,FDA的AI之路源远流长 在FDA的分类中,将具有AI赋能的医疗器械称为“AI/ML-Enabled Medical Devices”,即具有人工智能和深度学习的医疗器械。这里,有几个容易混淆的概念需要厘清。 首先是AI的内涵。伴随着技术的不断进展,AI的内涵一直在不断发展变化。目前,AI所采用的技术包括基于数据统...
在FDA的分类中,将具有AI赋能的医疗器械称为“AI/ML-Enabled Medical Devices”,即具有人工智能和深度学习的医疗器械。这里,有几个容易混淆的概念需要厘清。 首先是AI的内涵。伴随着技术的不断进展,AI的内涵一直在不断发展变化。目前,AI所采用的技术包括基于数据统计分析的模型、主要依赖于“if-then”语句的专家系统...
几年前,美国医学未来学家研究所(The Medical Futurist Institute,TMF)筛选了FDA审批的与人工智能相关的医疗设备,并建立了可公开访问的AI/ML医疗设备获批数据库https://medicalfuturist.com/fda-approved-ai-based-algorithms/ 指数级增长的AI医疗应用 截至2023 年 10 月 19 日FDA数据库资料显示,FDA共批准了 692 项...
Geeta Joshi, Aditi Jain, na Adhikari, Har Garg, Mukund Bhandari. FDA approved Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices: An updated 2022 landscape. medRxiv 2022.12.07.22283216; doi: https://doi.org/10.1101/2022.12.07.22283216. *封面图片来源:123rf 近 期 推 荐...
Radiology has witnessed the most significant integration of FDA-approved AI/ML technologies, accounting formore than three quartersof all FDA-cleared devices. These include sophisticated image-reading software algorithms seamlessly integrated into picture archiving and communication systems (PACS) from leading...
We performed comprehensive analysis of a total of 691 FDA-approved artificial intelligence and machine learning (AI/ML)-enabled medical devices and offer an in-depth analysis of clearance pathways, approval timeline, regulation type, medical specialty, decision type, recall ...
1.https://www.medicalplasticsnews.com/news/opinion/the-regulatory-changes-ai-brings-to-life-sciences/ 2.https://www.regulations.gov/document?D=FDA-2019-N-1185-0001 3.Benjamens, S., P. Dhunnoo, and B. Mesko,The state of artificial intelligence-based FDA-approved medical devices andalgorith...
https://medicalfuturist.com/fda-approved-ai-based-algorithms/ 该数据库包括每个批准的以下细节:设备或算法的名称;公司名称;简短描述;FDA批准号;FDA批准的类型;公告中提到AI/ML,如果FDA公告中没有提到AI/ML(URL);批准日期;与之相关的医学专业;与之相关的二级医学专业。
The technology — used in Australia, Canada, and Europe for the treatment of prostate cancer — was not approved for that indication in the United States because the device manufacturers were unable to demonstrate efficacy. Instead, the approval of HIFU was simply for "prostate ablation," leaving...
Contains Nonbinding Recommendations Draft – Not for Implementation Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions ___ Draft Guidance for Industry and Food and Drug Administration Staff DRAFT G...