精选理由
Neuracle的NEO拿了全球首张侵入式脑机接口注册证，但真正看点是三条中国路线和Neuralink抢FDA，2026年见分晓。
Neuracle的NEO于今年3月获中国国家药监局（NMPA）批准，成为全球首款注册的侵入式脑机接口设备。该证书体现的是监管审批速度，而非技术路线已定胜负。目前中国三条BCI路线——半侵入式、全带宽无线、超柔性皮层——均在推进临床试验。它们与Neuralink共同竞争美国FDA审批，预计2026年8月是关键节点。
原文 · Pandaily
How China Got Its BCI Regulatory First — and Why the Clinical Race Is Still Three-Wide
Neuracle's NEO became the world's first registered invasive brain-computer interface this March, but the certificate reflects regulatory speed, not a single dominant technology. Three Chinese BCI routes — semi-invasive, full-bandwidth wireless, ultra-flexible cortical — now race the FDA alongside Neuralink.