采用脑机接口技术的RACA机器人
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《采用脑机接口技术的医疗器械 RACA机器人运动意图编解码性能测试方法》医疗器械行业标准制修订项目正式立项
Zheng Quan Shi Bao Wang· 2025-09-22 07:28
Core Viewpoint - The National Medical Products Administration (NMPA) has approved the establishment of a new industry standard for medical devices utilizing brain-computer interface (BCI) technology, aimed at enhancing the quality development of these devices in response to regulatory needs [1] Group 1: Regulatory Developments - The NMPA has initiated the project for the revision of the standard titled "Performance Testing Methods for RACA Robot Motion Intention Decoding" [1] - The China National Institute for Food and Drug Control (NIFDC) is tasked with drafting, validating, soliciting opinions, and conducting technical reviews to ensure the quality and standards of the new regulation [1] Group 2: Technological Integration - The rapid advancements in neuroscience, artificial intelligence, and robotics are facilitating the integration of BCI technology with rehabilitation and compensatory medical robots (RACA robots) [1] - This integration offers innovative rehabilitation treatment options for patients with motor function impairments, such as those recovering from strokes or spinal cord injuries [1] Group 3: Impact on Industry - The establishment of this standard will provide objective evaluation methods for the safety, effectiveness, and reliability of RACA robots utilizing BCI technology [1] - It will also offer technical means for production, quality control, and regulatory compliance within the industry [1]