What happened
Sichuan Xinyuan Bioelectronics Technology built the BMP-10 anesthesia depth monitor. It records EEG through six forehead electrodes and shows a sedation depth index, the NSI. The report says that the company submitted research on an EEG detection algorithm based on machine learning. The Center for Medical Device Evaluation (CMDE) of China's National Medical Products Administration reviewed the application for Class III registration. For the NSI, the maker ran a prospective, multicenter, self-controlled trial with 140 patients at four clinical institutions. The reference standard was the MOAA/S sedation score. The NSI agreed with that score 90.62% of the time (95% CI 89.89% to 91.36%), which met the target. CMDE reports that the NSI agreed with MOAA/S more often than the BIS index did, a statistically significant difference. No patient had awareness during surgery, and no device-related adverse event occurred. CMDE concluded that “申请人提供的临床评价资料符合目前的临床审评要求” (the clinical evaluation data that the applicant provided meet current clinical review requirements). The report, posted on 23 October 2026, has no benefit-risk section and gives no figure for BIS.
Sources
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Regulatory document, by authors with no tie to the system.
NSI 指数与 MOAA/S 评分一致率高于 BIS 值与 MOAA/S 评分一致率且差异有统计学意义
综上,申请人提供的临床评价资料符合目前的临床审评要求。
Details
AI system
- Reported configuration
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Software release 1 (full version 1.0.0.143)
- Workflow
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Six electrodes on the patient's forehead recorded EEG. The monitor computed the sedation depth index (NSI) from quantitative EEG, with an EEG detection algorithm that the report says is based on machine learning. Sedation was scored on the MOAA/S scale as the reference.
Follow-up
- Conditions for replication
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The sedation depth index is meant for adult patients. Anesthetic drugs change the frontal EEG in a measurable way, which the index tracks.
Entry details
- Sector
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Healthcare.
- Purpose
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Sichuan Xinyuan Bioelectronics Technology built the BMP-10 monitor to record EEG in patients aged one and over and to show an index of sedation depth for adults under anesthesia.
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Cite this record
Peter H. Vartanian. (2026). BMP-10 sedation index tracked sedation scores better than BIS (AIBD-1160). Artificial Intelligence Benefits Database, edition of 1 November 2026. https://petervartanian.xyz/aibd/records/AIBD-1160.html (archived at https://doi.org/10.7910/DVN/AADSII, version 7.0)