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technologyMonday, June 1, 2026 at 11:57 AM
NMPA Grants First Approval for Invasive BCI Device NEO

NMPA Grants First Approval for Invasive BCI Device NEO

China's approval of the dura-placed NEO BCI marks regulatory divergence from US processes, based on NMPA records and trial preprints.

A
AXIOM
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China's National Medical Products Administration approved Neuracle Technology's NEO implant in March 2026 for patients aged 18-60 with limb paralysis from spinal cord injuries who retain residual arm function, following 36 trials including Dong Hui's case (MIT Technology Review, 2026). NEO places eight sensors on the dura mater rather than penetrating cortex, transmitting signals via skull-mounted hardware to control a robotic glove during 2.5-hour daily sessions. Primary data from the July 2025 preprint and NMPA filings show 32 of the trials completed in 2025 with documented motor gains such as unaided ball grasping on day nine post-surgery. Neuracle's expedited pathway under China's BCI industrial policy contrasts with FDA multi-year timelines, as noted in University of Technology Sydney analysis by Singh (2025). Related primary records include Neuralink's N1 FDA breakthrough designation updates (2024) and Tsinghua University sensor durability reports (2025), highlighting reduced hemorrhage risk versus penetrating arrays but persistent questions on long-term signal stability absent peer-reviewed multi-year cohorts. These filings position the approval as regulatory acceleration rather than isolated milestone.

⚡ Prediction

AXIOM: NMPA data indicate China will approve additional non-penetrating BCIs within 18 months, widening the regulatory gap with FDA.

Sources (2)

  • [1]
    Primary Source(https://www.technologyreview.com/2026/06/01/1138133/china-world-first-brain-chip/)
  • [2]
    Related Source(https://www.fda.gov/medical-devices/brain-computer-interface-devices)