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...
Geeta Joshi, Aditi Jain, Sabina Adhikari, Harshit 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 声明:动...
下面列出常用的链接:在FDA查询医疗器械注册情况进入FDA器械主页码http://www.fda.gov/MedicalDevices/default.htm在栏目:Approvals & Clearances 项下有 Recently-Approved Devices 510(k) Clearances PMA Approvals进入相应项,即可搜索查询 Recently-Approved Devices 510(k) Clearances PMA Approvals 国内正在注册的体外...
进入相应项,即可搜索查询 Recently-Approved Devices 510(k) Clearances PMA Approvals 国内正在注册的体外诊断试剂,在FDA上市的情况:https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm 510k文件有些查询结果这里可以直接下载: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/c...
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...
Kangyou medical products supplies market at home and abroad with its sophisticated devices to structure,reliable quality,also the operation idea has always insisted on "Honesy,Cooperation ,Innovation" to share prosperity with suctomers ,win -win situation...
https://www.fda.gov/medical-devices/recently-approved-devices/senza-spinal-cord-stimulation-scs-system-p130022s042 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7304671/ ▌关于申请 如果您或家人不幸被确诊为疑难疾病,并且已从其他信息渠道获悉美国有该病的治疗方案、专家、药物、临床研究等医疗资讯,有意...
下面列出常用的链接:在FDA查询医疗器械注册情况进入FDA器械主页码http://www.fda.gov/MedicalDevices/default.htm在栏目:Approvals & Clearances 项下有 Recently-Approved Devices 510(k) Clearances PMA Approvals 进入相应项,即可搜索查询 Recently-Approved Devices ...
为了获得批准或设备许可,贵公司需要提交的信息类型在http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm的互联网上有描述。FDA将评估贵公司提交的信息,并决定该产品是否可以合法销售。 Our office requests that Nikkiso America, Inc. immediately cease activities that ...
Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved IMDELLTRA™ (tarlatamab-dlle) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with...