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...
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...
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....
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...
To date, a considerable number (i.e., 63) of biologic-device combination products have been approved by FDA and introduced to the global market, where insulin and vaccine related products are not counted. While PFS, autoinjectors and pen injectors remain as the mainstay of medical devices, ...
/PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved LUMAKRAS® (sotorasib) in combination with...
Table 1. US FDA-Approved IUDs Insertion—Removal Costs and Side Effects According to the Student Life University Health Service at the University of Michigan, inserting any of these devicescosts$202. In contrast, removing an existing device is priced at $210. If both removal and ...
FDA-Approved Drug Lasmiditan Promotes Mitochondrial Biogenesis and Accelerates Recovery of Renal Function After Ischemia/Reperfusion Injurydoi:10.1681/ASN.20223311S1364cKevin A. HurtadoThe University of Arizona College of Pharmacy, Tucson, AZJaroslav Janda...
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...
Apple is adding a feature to the AirPods Pro 2, and the FDA has just approved them to work as a “hearing aid software device.”