Shanghai Haimaikang Intelligent Medical Secures China's First Neurointerface-Driven Hand Function Assistance System Registration Certificate

(Source: Shanghai Observer)

Reporter learned from the Digital Intelligence Health Industry Working Group of Putuo District that AI CARE Medical Technology Co., LTD, a company in the jurisdiction of Putuo, successfully obtained the first medical device registration certificate in China for a hand function assistance system driven by neural interface on January 7, 2026. This means that hand exoskeleton devices used for rehabilitation assistance in treating diseases such as stroke will accelerate into patients' lives.

Stroke, commonly known as "apoplexy," is notorious for its high incidence, high disability rate, high mortality, and high recurrence rate, with the autumn and winter seasons being its peak periods of onset. Data shows that the total number of stroke patients in China exceeds 28 million, and the onset of the disease is showing a trend of affecting younger individuals. Movement dysfunctions caused by this type of nervous system injury require long-term rehabilitation training, with hand dysfunction once leaving countless patients trapped in the dilemma of "wanting to move but being unable to."

Wu Qinfeng, Chief Physician of the Rehabilitation Medicine Center at Putuo District People's Hospital, introduced that stroke is one of the most common diseases among inpatients in the rehabilitation discipline. Patients often experience upper or lower limb dysfunction, severely impacting their daily living abilities and those of their families. "Current methods to assist stroke rehabilitation training include one-on-one functional electrical stimulation and transcranial magnetic stimulation within hospitals, as well as rehabilitation robots and exoskeleton devices."

Headquartered in Putuo, AI CARE Medical Technology Co., LTD, located in Putuo District in 2020, has recently received approval for registration of its self-developed hand function assistance system driven by neural interfaces (commonly known as hand exoskeletons). This product took approximately five years to develop. Patients can control the exoskeleton movement through "thoughts" to complete rehabilitation training for hand mobility. During the R&D period, the company also collaborated with multiple medical institutions to complete clinical validation of the product.

At the company's R&D base located in Taopu, Putuo, reporters saw that this hand exoskeleton device is made entirely of soft steel. Its size is similar to an ordinary glove, and it can be used after wearing the elastic assistive device. The core neural interface drive module was independently developed by the company. Through a collection device fixed on the forearm, it can accurately capture the user’s electromyographic signals.

"This module can simultaneously collect signals from the flexor and extensor muscle areas to detect the patient's movement intentions. By analyzing subtle changes in the signals, it determines whether the patient intends to reach out or make a fist, thereby enabling the picking up and releasing of objects of different shapes and sizes," explained Wang Yang, the company's R&D director.

Speaking about the advantages of this device, Wang Yang said, "Traditional rehabilitation equipment mostly operates in a passive stretching mode, which does not require active participation from patients and is only suitable for musculoskeletal rehabilitation training. However, for patients with nervous system injuries, this model cannot address the core rehabilitation issues. The essence of rehabilitation for patients with central nervous system injuries is to achieve the remodeling of functional areas in the nervous system. To accomplish this goal, it is essential for patients to actively participate in the rehabilitation process, driving hand movements through conscious intention."

As China’s first registered neural interface-driven "hand function assistance system," this device allows patients' brains to regain control over the movement of their affected hands, bringing new hope for functional reconstruction to countless stroke patients with hand dysfunction. "Clinical trial results show that after wearing the exoskeleton, the average improvement in motor function scores was 69.29% higher than without it, achieving a leap from being unable to grasp objects to performing grasping actions independently," said Wang Yang.

It is reported that obtaining the medical device registration certificate means that the product has completed the entire process of technology development, clinical verification, and standard compliance, and officially qualifies for market launch. Geng Xiaoyang, the assistant to the general manager of the company, calculated that the revenue of this equipment is expected to reach 20-30 million yuan by 2026, and subsequent revenue will increase year by year. In an optimistic estimate, it could exceed 200 million yuan at most after three years.

In the process of enterprises developing related equipment, the upstream and downstream linkage of Putuo District's life and health industry empowers like a vibrant "tropical rainforest," gathering strong synergy for enterprise innovation and development. Not long ago, facilitated by the Putuo District Commerce Commission, Putuo District People's Hospital and AI CARE reached a cooperation intention, unveiling the first joint research base for smart rehabilitation in Putuo District. This will become the first rehabilitation research base within the soon-to-be operational Putuo District Rehabilitation Hospital this year. In the future, it will provide modern rehabilitation treatment for residents of Putuo District and the entire city, with plans to introduce related exoskeleton rehabilitation equipment into the research base.

Lu Wei, Party Committee Deputy Secretary and President of Putuo District People's Hospital, introduced that the term "rehabilitation" now goes beyond the traditional passive rehabilitation model. This requires medical institutions to actively incorporate high-tech methods such as artificial intelligence and new equipment when providing rehabilitation services to patients. As frontline practitioners of medical services, clinical medical staff can accurately identify clinical needs and practical issues during diagnosis and treatment. In response, research and development enterprises can focus on these needs to carry out targeted product development. This is a vivid example of the integrated development model of "industry-university-research-medicine" in the digital and intelligent health industry.

The life and health industry is one of the four key industries that Putuo District focuses on developing during the "14th Five-Year Plan" period. By the end of 2024, the district's four key industries had completed the "411 Doubling Plan" ahead of schedule, with their share of district-level tax revenue doubling compared to the end of the "13th Five-Year Plan." Since the "14th Five-Year Plan," there have been over 3,500 life and health enterprises in the district, and a complete industrial chain layout has basically taken shape. By the end of 2025, the scale of related industries reached 72.6 billion yuan, accounting for more than 6% of district-level tax revenue, with economic contribution increasing by over 10% year-on-year, providing solid industrial support for regional development. Looking towards the "15th Five-Year Plan," Putuo District has proposed efforts to build a modern industrial system centered around the "1+2+3" framework, where the "2" corresponds to the goal of creating a 100-billion-yuan leading industrial cluster related to intelligent health by 2030.

Original Title: "The First Medical Device Registration Certificate in China for a Neural Interface-Driven 'Hand Function Assistance System' Goes to Putuo"

Source: Author: Zhou Nan from Jiefang Daily, Communicator: Wang Di