FDA clears Precision Neuroscience Layer 7 array for 30-day implantation
植入时长30 天此前30 分钟通道数1024路径510(k)
Summary
The device was previously cleared only for intraoperative use up to 30 minutes. Extending to 30 days opens the door to longer-duration clinical studies.
Why it matters
First thin-film electrode product cleared for long-duration implantation, setting a regulatory reference point for Chinese players on the same technical route.