Siyi Intelligence Secures NMPA Approval for Breakthrough BCI-Powered Rehabilitation Robots and Launches Next-Gen Upper Limb System Globally

In China's billion-dollar rehabilitation market, a dark horse is galloping, breaking down the barriers between professional in-hospital rehabilitation and long-term out-of-hospital management.

Rehabilitation spans the entire human life cycle and directly determines the recovery of a patient's physical functions. Particularly for patients with conditions such as stroke or fractures, timely and professional rehabilitation treatment is crucial. In recent years, with the aggravation of population aging, the demand for rehabilitation has grown rapidly. At the national level, efforts are actively underway to promote a three-tier rehabilitation medical service system. The settings for rehabilitation treatment have gradually expanded from mainly being in the rehabilitation departments of tertiary hospitals to include secondary rehabilitation specialty hospitals and community health service institutions. Meanwhile, constrained by shortages of medical resources and insufficient numbers of rehabilitation therapists, out-of-hospital rehabilitation has become a focal point, but there remains a lack of professional home-use rehabilitation devices.

Traditional large-scale rehabilitation equipment can no longer meet the application needs of multi-scenarios.The introduction of advanced technologies such as soft robotics and brain-computer interfaces has transformed traditional passive rehabilitation into intelligent, active rehabilitation therapy. Moreover, in the increasingly competitive rehabilitation market, these high-end fields remain a blue ocean, awaiting pioneers to explore.Among them, SIYI INTELLIGENCE has taken the lead. The company is committed to building a full-cycle intelligent rehabilitation system covering "hospital-community-family," and has launched a new generation of upper limb rehabilitation robots that are lighter and easier to use, as well as the world's first brain-computer interface soft rehabilitation robot.

Recently, these two innovative products have made breakthrough progress. SIYI INTELLIGENCE's "Yisheng Upper Limb Intelligent Rehabilitation Training and Assessment System" has obtained the Class II medical device registration certificate from the National Medical Products Administration. This is currentlyThe Lightest and Most Portable Upper Limb Rehabilitation Robot in China, the First to Use Optical Positioning, Suitable for Multi-Scenario Applications Including Hospitals, Communities, and Homes;"Yisheng Brain-Computer Interface (BCI) Rehabilitation Training and Assessment System" won two of the world's top design awards, Red Dot and iF.The first and currently the only brain-computer interface hand function rehabilitation robot product in China with a medical device registration certificate.。

Brain-computer interface technology offers patients a completely new mode of active rehabilitation training. It establishes an information pathway between the patient's brain and external devices, enabling control of external devices such as robotic arms through neural feedback, thereby achieving "top-down" neural remodeling. Brain-computer interface technology overturns traditional passive rehabilitation models, truly engaging the proactive thinking of patients.

Several giants at home and abroad are exploring the application of brain-computer interface technology in different fields, but there are few projects that have been implemented. Even fewer are used in the rehabilitation field and achieve mass production. In addition to technical barriers such as neural signal processing and setting the bandwidth of brain-computer interfaces, the design and safety of brain-computer interface devices also affect their clinical applicability.SIYI INTELLIGENCE's YiSheng Brain-Computer Interface Rehabilitation Training and Assessment System is the first brain-computer interface soft hand function rehabilitation robot in China to obtain a medical device registration certificate and achieve clinical implementation.

SIYI INTELLIGENCE Brain-Computer Interface Rehabilitation Training and Assessment SystemIntegrating Flexible Actuation and Neuroscientific Technologies, significantly improving product safety, operability, and convenience. The system is equipped withMultiple Safety Settings, patented pneumatic and sensing technology, can effectively avoid secondary injury; hasFull-Cycle Hand Function Rehabilitation Training Model, including muscle strength/joint range of motion/cognitive/ADL daily living skills/coordination/context multi-dimensional training, can simultaneously intervene in central and peripheral nerves; overallCompact and Portable, supports both charging and plugging, can be extended to a larger screen, meeting the multi-scenario needs of hospitals such as bedside and hall; high-definition touch screen combined with an intelligent human-computer interaction interface,Simple and convenient operation; During useFull Record of Patient's EEG Data, to generate EEG training reports and assist rehabilitation therapists in management.

In addition, in terms of product design, the YiSheng Brain-Computer Interface Rehabilitation Training and Assessment System uses elastic fabrics and seamless sewing technology to ensure even pressure distribution on the patient's hand, avoiding skin damage. The rehabilitation gloves come in various sizes to meet the needs of patients with different hand shapes. Through the YiSheng Brain-Computer Interface Rehabilitation Training and Assessment System, patients can achieve multi-dimensional, multi-scenario, and self-driven rehabilitation therapy, significantly improving clinical rehabilitation efficiency and effectively reducing the disability rate.

It is precisely based on the leadership in technology and design,SIYI INTELLIGENCE's Brain-Computer Interface Rehabilitation Training and Assessment System won two international awards, the German Red Dot and iF, receiving authoritative recognition from two of the world's top three design awards.。

Currently, the SIYI INTELLIGENCE Brain-Computer Interface Rehabilitation Training and Assessment System has achieved mass production globally for the first time. It has been introduced in many well-known tertiary hospitals in China and has gained widespread recognition from clinical experts. The successful implementation of this product not only provides a brand-new solution for clinical hand function rehabilitation treatment but also sets an example for the application of subsequent brain-computer interface innovative products, accelerating the industrialization of brain-computer interface technology.

The growing demand for rehabilitation inside and outside hospitals has placed further requirements on rehabilitation devices — precise and efficient in hospitals; simple and easy-to-use outside hospitals. Based on this, SIYI INTELLIGENCE has launched a new generation of the YiSheng Upper Limb Intelligent Rehabilitation Training and Assessment System.

Traditional upper limb rehabilitation robots on the market are mostly integrated machines, which are large in size and heavy in weight, making them extremely inconvenient for multi-scene transfers within hospitals or for use in community and home settings outside hospitals. Moreover, these rehabilitation robots are mostly designed with a linkage mechanism, which has problems such as inaccurate positioning and low precision, resulting in limited rehabilitation effects and a poor user experience for patients.

SIYI INTELLIGENCE Upper Limb Intelligent Rehabilitation Training and Assessment System AdoptedOmni-directional mobile chassis and high-precision optical positioning technology, with a positioning accuracy of up to 0.03mm, provides diverse, customized goal-oriented training for users with muscle strength levels 0-5, covering the entire rehabilitation cycle of patients. The system features passive mode, assistive mode, active mode, and resistance mode, enabling multi-dimensional training, andCan monitor users' speed, strength, range, and other parameters in real time., feedback on recovery status, thereby dynamically adjusting rehabilitation training plans in a timely manner to achieve closed-loop management of the rehabilitation process. The product is compact and portable, with a small main unit volume and a weight of only 8kg, making it not only easy to move within the hospital but also increasing the possibility of its application outside the hospital.

As a product developed through the integration of medical and engineering expertise, the SIYI INTELLIGENCE Upper Limb Rehabilitation Training and Assessment System has a certain clinical foundation. After obtaining NMPA approval,The product has gained widespread clinical recognition through clinical trials and has already achieved large-scale production.。

Under the Trend of Aging, There Is a Huge Demand for Rehabilitation Therapy in China and Even Globally Waiting to Be Met. According to statistics from The Lancet, more than 2.41 billion people worldwide may benefit from rehabilitation therapy during illness or injury. China has the largest rehabilitation demand globally, with the total number of people in need of rehabilitation reaching 460 million in 2019. However, issues such as insufficient public awareness of rehabilitation, a shortage of rehabilitation therapists, and a lack of rehabilitation equipment have led to a currently low rate of rehabilitation therapy.

The emergence of intelligent rehabilitation equipment such as rehabilitation robots has, to a certain extent, addressed the imbalance between supply and demand in rehabilitation treatment. Among these, soft robotics represents a significant direction in the development of rehabilitation robots, offering multiple degrees of freedom with a simple structure; however, they are still some way from large-scale commercial application. At the same time, the concept of full-life-cycle rehabilitation therapy has been repeatedly emphasized at the national level, making consumer-grade robots that cover out-of-hospital applications an important developmental direction.

SIYI INTELLIGENCE, while breaking through cutting-edge technologies such as soft robotics and brain-computer interfaces, also considers the practical application of rehabilitation robots.Product Positioning: "Professional Rehabilitation Robot for Consumer Use", improving the efficiency and accessibility of patient rehabilitation throughout their entire life cycle. The company's two core products, the "Yisheng Brain-Computer Interface Rehabilitation Training and Evaluation System" and the "Yisheng Upper Limb Intelligent Rehabilitation Training and Evaluation System," are important manifestations of its development philosophy. They will drive SIYI INTELLIGENCE to accelerate coverage of both in-hospital and out-of-hospital rehabilitation markets, creating a more comprehensive solution for full life cycle rehabilitation systems.

It is on the basis of innovative technologies and differentiated products that SIYI INTELLIGENCE has successfully gone global, exporting Chinese wisdom to various parts of the world. The company's brand, Syrebo®, has been adopted by several well-known overseas medical institutions, including the Royal Buckinghamshire Hospital in the UK, Hobbs Rehabilitation Center (the largest community rehabilitation chain center in the UK), Homerton University Hospital, Manoos Brescia Rehabilitation Center in Italy, and the Ural Neurorehabilitation Center in Russia.

In August, Prof. Dr. C. Gutenbrunner FRCP, former Dean/Chief/Director of the Rehabilitation Hospital at Hannover Medical School, WHO Liaison Officer for Rehabilitation Medicine, and Founder & Executive Director of the WHO Global Rehabilitation Alliance, led a delegation to visit SIYI INTELLIGENCE. He highly praised the company's Brain-Computer Interface Rehabilitation Training and Assessment System, stating that the "product concept is ingenious and the R&D technology is advanced." During the process of learning about and experiencing other rehabilitation products from SIYI INTELLIGENCE, Academician Gutenbrunner also noted that the emphasis on the "hospital-community-home" module in Yisheng's home-use product line aligns perfectly with his proposed "therapist-engineer-patient" philosophy.

Currently,SIYI INTELLIGENCE's multiple products have obtained authoritative certifications such as China NMPA, U.S. FDA, and EU CE, entering more than 80 countries, over 3,000 medical institutions, and more than 50,000 households., serving millions of people worldwide and recognized by professional rehabilitation institutions, therapists, and patients in multiple countries. The company is gradually building a stable sales channel globally and progressively expanding its e-commerce sales business targeting end consumers. The application of its products is expected to grow further, accelerating the realization of the vision to "make innovative rehabilitation services accessible to all."