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China Clears Two Brain Chips For Sale, Not Just Trials

China's National Medical Products Administration has approved brain-computer interface devices from StairMed and NeuCyber NeuroTech for market sale, the first BCI approvals of their kind in the country. Both are invasive systems, meaning electrodes sit on or in the brain rather than reading signals through the skull, and both were built to let patients with paralysis move a cursor or a robotic limb by intent alone. The mechanism is the same one Synchron and Neuralink use: an implanted array picks up the electrical spikes neurons fire when a patient imagines moving, a decoder trained on that patient's own signals translates the spike pattern into a cursor position or a grip command, and the software updates that mapping as the neurons drift. What's new is the stage. Neuralink and Synchron are still running staged human trials under FDA investigational device exemptions. A market approval means a Chinese hospital can now implant one of these two systems in a patient without a trial protocol, which is a regulatory first for the field anywhere.

The same week, Butterfly Network licensed its ultrasound-on-chip technology to Merge Labs, the BCI startup Sam Altman is backing, to build a non-invasive interface that reads brain activity through the skull using sound waves rather than surgery. That's the other branch of this technology: skip the implant, trade signal resolution for zero surgical risk. Neither approach has solved the problem that decides whether BCIs move past paralysis care, which is durability. The electrodes StairMed and NeuCyber implanted scar the tissue around them over months, and signal quality typically degrades within one to three years, the failure mode every chronic BCI trial to date has run into. Watch NMPA's post-market surveillance filings, due at the one-year implant mark for the first patients, for whether either device holds a stable decode past the point where every prior implant has failed.

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