Mind-Reading Glove: Putuo-Based Company Secures Breakthrough Medical Device Certification to Restore Grasping Ability in Stroke Patients

(Source: Shanghai Observer)

Stroke, commonly known as "apoplexy," is characterized by high incidence, high disability rate, high mortality, and high recurrence rate. Data shows that the total number of stroke patients in China has exceeded 28 million, with most patients often experiencing upper or lower limb dysfunction, seriously affecting their own and their families' daily lives. The incidence of stroke is also showing a trend of affecting younger individuals.

Currently, it is the peak season for diseases in autumn and winter. Recently, a hand exoskeleton device used for rehabilitation assistance in diseases such as stroke has obtained the first medical device registration certificate in China for a neuro-interface driven hand function assistance system. This means that stroke patients now have a more "active" option for hand function rehabilitation training. What does this device, which can understand the patient's "intent," look like? And how does it work?

Neural Interface Collects Signals to Detect Patients' "Thoughts"

At the R&D base of AI CARE Medical Technology Co., LTD, located in Taopu, Putuo, Shanghai, reporters observed that this hand exoskeleton device is similar in size to an ordinary glove. Patients can use it after wearing the elastic assistive device. Its core neural interface drive module, independently developed by the company, accurately captures the user’s electromyographic signals through a collection device fixed on the forearm.

"This module can simultaneously collect signals from the flexor and extensor muscle areas to detect a patient's movement intention. By analyzing signal changes, 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," introduced Wang Yang, the company's R&D director.

Currently, the conventional means for assisting stroke rehabilitation mainly include functional electrical stimulation, transcranial magnetic stimulation, as well as rehabilitation robots and exoskeleton devices.

Among them, traditional external skeleton rehabilitation devices are mostly passive traction modes, which do not require active participation from patients. Although they are suitable for musculoskeletal rehabilitation training, they cannot address the core rehabilitation issues. For patients with central nervous system injuries, the essence of rehabilitation is to achieve the remodeling of functional areas in the nervous system. Therefore, it is essential for patients to actively participate in the rehabilitation process by driving hand movements through active "intention." This product was specifically developed to meet this core need. Clinical trial results show that after wearing the device, the average improvement in patients' motor function scores reached 69.29% higher than without wearing it, largely achieving the leap from being unable to grasp objects to independently completing grasping.

Accelerated Approval for Innovative Medical Devices

The National Medical Products Administration has clear requirements for products entering the special review channel for innovative medical devices, mainly including independent intellectual property rights and clinical application value.

The approval of this medical device registration certificate is based on an original breakthrough in neural interface technology, rather than the iteration of mature technology, while also filling the gap in a niche field. This marks a key transition for China-produced neural interface technology in the rehabilitation medical device sector from "research and development" to "clinical application," serving as an industry benchmark.

AI CARE Medical Technology Co., LTD, located in Putuo District, was established in 2020. The company has laid out multiple invention patents around the hand function auxiliary system, covering overall design, algorithms, structure, and electronic circuits.

It is reported that the current scale of the digital intelligence health industry in Putuo District has reached 72.6 billion yuan, accounting for over 6% of the district's tax revenue. Looking forward to the "15th Five-Year Plan," with the Taopu area as the main carrier, Putuo District will fully build a leading industrial cluster of digital intelligence health worth hundreds of billions. This positioning marks the vigorous rise of an industrial cluster led by digital intelligence health and characterized by smart healthcare.

Original Title: "Mind-Reading in Gloves: Putuo Company Obtains Breakthrough Medical Device Registration Certificate, Helping Stroke Patients Regain Grip Strength"

Column Editor: Gu Yingying

Source: Author: Xinmin Evening News, Xie Min; Correspondent: Wang Di