截至到2022年12月31日,CDRH已将 135 台设备纳入了“突破性设备计划”(自2015年计划成立以来,总共 752 个设备被纳入“突破性设备计划”),并授予19个“突破性设备”的市场授权。 ▍什么是“突破性设备计划”? 突破性设备计划(Breakthrough Devices Program) 是美国食品药品监督管理局(FDA)于2015年4月启动的一种...
以推想医疗的“颅内出血CT图像辅助分诊软件(InferRead CT Stroke.AI)”为例,FDA于2021年8月以510(k)方式批准该产品上市,分级为2类医疗器械;但在国内则以三类医疗器械管理,于2022年6月获准上市。 推想医疗的“颅内出血CT图像辅助分诊软件”在国内以三类医疗器械获批(截图自NMPA官网) 在FDA则以二类医疗器械获批(截...
The FDA’s approval process has garnered many criticisms over the years. For one, generic drugs and devices often make it to market simply because the manufacturers can demonstrate they are similar to products that were approved in the past — even if those products have known safety concerns....
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...
截至到2022年12月31日,CDRH已将 135 台设备纳入了“突破性设备计划”(自2015年计划成立以来,总共 752 个设备被纳入“突破性设备计划”),并授予19个“突破性设备”的市场授权。 什么是“突破性设备计划”? 突破性设备计划(Breakthrough Devices Program) 是美国食品药品监督管理局(FDA)于2015年4月启动的一种加快...
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in combination with...
SMITHFIELD, R.I. , April 28, 2022 /PRNewswire/ --Acclaro Corporation, (formerly FA International LP, Boston, Mass.), breaks new ground in medical devices for aesthetics with their revolutionary UltraClear™ system. This disruptive technology features a no downtime, painless treatment...
Apple's newly announced hearing aid capability is officially the first over-the-counter (OTC) hearing aid software to be approved by the FDA. And it should be available on devices soon. The federal agency formally ushered in the tech giant's new "Hearing Aid Feature" (or HAF, as the ...
链接三分之一FDA批准药物存安全隐患据合众国际社报道,布莱根妇女医院(Brigham and Women's Hospital…
As of November 2022, the FDA has approved 14 different ADCs, including Lumoxiti (moxetumomab pasudotox-tdfk), which we consider an immunotoxin. The listing of Antibody-drug conjugates(ADCs) Approved by FDA: ADC Drug Trade name Maker Disease Indication Payload/Payload Class Payload Action Target...