Breakthrough in Brain-Computer Interface: First-In-Class Implantable System Secures Medical Insurance Code Within Two Days of Approval

The first gateway for brain-computer interfaces to move into clinical applications has been opened.

01

World's First Invasive Brain-Computer Interface

On March 22, the National Medical Security Administration released a message,World's First Brain-Computer Interface Innovation Product Receives Medical Insurance Code。

According to the National Healthcare Security Administration, on March 13, the world's first invasive brain-computer interface medical device was officially approved for marketing. On March 15, the National Healthcare Security Administration took the initiative to connect and provide upfront services.Complete the medical insurance coding for this product, successfully打通ing the critical环节 from regulatory approval to clinical application for innovative products., marking that the brain-computer interface industry has officially shifted from the "planning blueprint" to the "fast lane of implementation".

The successfully launched brain-computer interface product this time isNeuracleMedical Technology (Shanghai) Co., Ltd.Implantable Brain-Computer Interface System for Hand Motor Function CompensationThis medical device certification demonstrates that invasive brain-computer interfaces have completed the closed-loop verification process in China, transitioning from scientific research concepts and clinical exploration to regulatory evaluation and registration approval.

It is reported that,This product is expected to achieve its first clinical application within the year.。This product is mainly aimed at patients aged 18 to 60 who suffer from quadriplegia due to cervical spinal cord injury and are unable to complete grasping with their fingers.

According to the introduction by the National Healthcare Security Administration,This product involves implanting a minimally invasive device, about the size of a coin, into the patient's skull, allowing the system to collect and decode brain electrical signals in real time.. Only one month after the surgery, patients can operate independently at home.

This breakthrough provides a brand-new "Chinese solution" to the world-class medical challenge of spinal cord injury repair. Compared with similar technologies abroad, this product has significant advantages in trauma control, patient compliance, and long-term stability, solving the pain points of traditional invasive technologies, such as large trauma and the need for maintenance by professional teams.

It only took two days from obtaining the certificate to receiving the medical insurance code.Brain-computer interface products in China are transitioning from laboratories to clinical settings and moving towards industrialization at an unprecedented speed.

02

Dual Drivers of Policy and Capital in China

Invasive Brain-Computer Interfaces Enter the "Order" Phase

Compared with non-invasive brain-computer interfaces, invasive products typically place electrodes inside the skull or close to brain tissue through surgery, thus enabling higher quality and higher resolution neural signals. They are suitable for clinical applications with higher requirements for control precision, stability, and real-time performance, but also impose higher demands on safety, long-term stability, surgical capability, and regulatory review, presenting relatively higher technical barriers.

It is reported that, in addition to Neuracle, which has taken the lead in obtaining certification,StairMed and NeuroXess's invasive brain-computer interface products have also entered the clinical trial stage.

In terms of international progress, Musk's Neuralink received FDA approval in May 2023 to conduct human clinical trials, and successfully implanted the device in the first subject (PRIME study) in January 2024, achieving mind-controlled mouse and simple games.

As of September 2025, 12 patients with severe paralysis worldwide have been implanted with the device, enabling them to perform functions such as gaming, web browsing, and live streaming interactions. On January 1, 2026, Musk announced that Neuralink plans to initiate mass production of the device in the same year and advance the full automation of the surgical process.

Brain-computer interfaces have become an innovation focus and are highly favored by capital.Currently, several leading companies have received substantial capital injections, the industrial cluster effect is gradually emerging, and the mid-to-downstream sectors have become the core focus of capital deployment.

Recently,StairMed Announces Completion of 500 Million Yuan Strategic Financing, byAlibabaLed by, Origin Capital, Orbimed, Yuanhe Origin, Qiming Venture Partners, Lilly Asia Ventures, Source Code Capital, and other well-known investment institutions in China participated, with Tencent also listed as an investor.

StairMed revealed that the company plans to launch a large-scale, multi-center registration clinical trial by mid-2026, aiming to complete patient enrollment and implant surgeries on a certain scale within the year. This will make StairMed the second company globally, after Neuralink, to enter the clinical stage for invasive brain-computer interface technology.

Another invasive brain-computer interface companyZhiran Medical, which has recently completed a 300 million yuan A+ round of financing. In August 2025, Zhiran Medical had just completed an over 300 million yuan A round of financing.Within half a year, Zhiran Medical has achieved 600 million yuan in financing.

Despite the high热度 in the capital market, for the brain-computer interface industry that is already at a transformation node,The key to industrialization is who can produce the product and make it acceptable for use by hospitals and patients.。

The institutional connection at the medical insurance end becomes the key to打通脑机接口的“临床入口”.For the frontier field of brain-computer interfaces, China's National Healthcare Security Administration has proactively launched a series of empowering initiatives.

In March 2025, the Guidelines for the Establishment of Medical Service Price Items for Nervous System Services were issued, specifically establishing price items related to invasive and non-invasive brain-computer interfaces, paving the way for new technologies to enter clinical applications through payment channels. In September of the same year, the National Healthcare Security Administration publicly solicited information on innovative medical consumable products such as brain-computer interfaces and surgical robots, conducting preliminary studies on product coding and classification to continuously improve the classification and coding system for medical consumables under healthcare security.

Locally, the medical service systems of multiple provinces in China have already set up "price anchors" for the rapid implementation of brain-computer interface products.

According to statistics from Northeast Securities,Zhejiang, Hubei, and 29 other provinces and cities in China have included brain-computer interface rehabilitation-related projects in the scope of medical insurance payments.At the charge and pricing level, provinces and cities across China have responded positively to the deployment:Hubei, JiangsuSpecific prices and maximum price caps for invasive insertion, removal, and non-invasive fitting procedures have been clarified in various regions;ZhejiangStarting from September 1, 2025, the "Non-invasive Brain-Computer Interface Fitting Fee" will be officially included in the Class B payment scope of basic medical insurance, stipulating that individuals can be reimbursed after paying 10% out-of-pocket, and its use will be restricted to intelligent bionic prosthetics.ShanghaiDelegate pricing power to hospitals, supporting medical institutions in setting their own prices;GuangdongThen, the formulation of charging items and the implementation of medical insurance payments will be advanced simultaneously.

Once the technology matures, medical institutions can charge compliantly according to existing policies, providing institutional guarantees for the implementation and promotion of the technology.

The rapid establishment of a supporting security mechanism within the medical insurance system has broken through the first bottleneck for the routine clinical application of brain-computer interfaces. The institutional end is already prepared to integrate new technologies, and the industrial end is also about to reach the crucial threshold of transitioning from laboratories to real-world application scenarios.

Source: Saibailan Medical Devices

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