Recently, brain-machine interface surgery has been making headlines, and the 1.5-second rapid implantation technology is truly shocking. But this also reflects a deeper issue—the strictness of AI medical device validation requirements.

The reason why surgical robots are trustworthy boils down to one word: precision. Even a tiny error could mean life or death, so every step must be uncompromising. Now, as robotic technology advances toward greater autonomy, a problem arises—higher autonomy means more complex risk interfaces. If the validation system is not upgraded in sync, no matter how advanced the technology is, it’s useless.

This is actually a challenge faced by the entire AI medical field: how to synchronize innovation speed with safety validation?