FDA试点允许生成式AI医疗设备提前上市
STAT+: FDA pilot offers generative AI medical devices a path to patients before they are authorized
精选理由
FDA推出新试点，让Cadence和Limbic的AI医疗设备提前进入市场，改变传统审批流程。
FDA启动TEMPO试点项目，接受四款生成式AI医疗设备。Cadence和Limbic的产品位列其中。这些设备可在未获营销授权前向患者提供。试点项目为数字健康公司提供新路径。
原文 · STAT News · Health Tech
STAT+: FDA pilot offers generative AI medical devices a path to patients before they are authorized
AI products from Cadence and Limbic are among four devices recently accepted into the FDA’s TEMPO pilot that will allow digital health companies to release products without marketing authorization.
