Zhejiang-Made Medical Devices Achieve Breakthroughs in AI and Brain-Computer Interface Innovations

Patient with Severe Depression in Zhejiang Recovers after Implanting Miniature Brain-Computer Interface Device

This is not only a technological miracle but also a microcosm of Zhejiang's deep cultivation in the field of medical device innovation — from AI-assisted diagnosis to surgery.Robot, from brain-computer interfaces to vision reconstruction, a group ofInnovative HealthcareEquipment is rapidly emerging in this fertile industrial landscape.

How AI Becomes a "Super Partner" for Doctors?

Traditional radiologists need to manually annotate detected lesions in hundreds of images, which is time-consuming and labor-intensive. Especially in image reconstruction, it often takes an experienced radiologist a significant amount of time for manual reconstruction. However, with the assistance of AI technology, while ensuring accurate results, this process is significantly shortened.

In the demonstration hall of Deepwise & League Technology Co., Ltd., lung CT images on the screen are analyzed in real time, suspicious lesions are automatically marked, and preliminary diagnosis suggestions are provided to doctors.

"We are committed to exploring the 'AI + Doctor' model, making our products a good partner for doctors," said Feng Yan, the company's marketing director. The company provides multimodal general medical AI solutions for medical institutions at all levels in China. Its products cover diagnostic fields of multiple systemic diseases, including the respiratory system and the cardiovascular and cerebrovascular systems, offering end-to-end artificial intelligence services to thousands of medical institutions across China.

With the help of AI, hospitals' reception capacity has improved, doctors' growth has accelerated, and patients' experience has been enhanced, achieving a "win-win-win" situation.

If AI is the doctor's "external brain," then surgical robots are the doctor's "iron body." In the exhibition hall of Hangzhou Lancet Robot Co., Ltd., surgical robots covering fields such as joint replacement and spinal trauma are neatly arranged. These 100% China-produced devices have achieved breakthroughs such as preoperative 3D planning and submillimeter-level high-precision operations.

Zhang Huanyu, the product manager of the company's marketing department, introduced that, compared with traditional surgery, surgical robots have core advantages such as precision, minimal invasiveness, high efficiency, and high repeatability. They can significantly improve the quality of surgery, shorten patients' recovery time, and bring better treatment outcomes to patients.

How Brain-Computer Interfaces Read Emotions and Reshape Perception?

Brain-computer interface, this cutting-edge technology, is opening up new fields in medical applications.

Hangzhou Qingshi Yongjun Medical Equipment Co., Ltd. has set its sights on the global challenge of treatment-resistant severe depression.

"About 30% of patients with depression suffer from treatment-resistant severe depression. The fully autonomous intellectual property miniature wireless brain-computer interface treatment system we developed provides personalized treatment plans for these patients through three unique core technologies: calibrating emotional markers, selecting personalized treatment targets, and optimizing closed-loop stimulation parameters," said Hu Xiongjie, the general manager.

Nanochap Electronics Co., Ltd., also deeply engaged in the brain-computer interface field, has made breakthroughs in high-resolution visual brain-computer interfaces. In the near future, enabling the blind to "see" will no longer be a "fantasy."

"Brain-computer interface technology is divided into two directions: signal reading and writing. The company focuses on visual reconstruction, which involves both writing signals to the brain and reading neuronal action potential signals, forming a closed-loop control. In the future, brain-computer interfaces will have more applications in the field of sensory restoration, including the reconstruction of vision, hearing, touch, smell, and more," explained Lin Ke, the company's vice president.

Taking visual reconstruction as an example, the principle is to capture image information through external devices, and then convert the image information into electrical signals that stimulate neurons via neural encoding and decoding algorithms. These signals are ultimately transmitted to the visual cortex, achieving a certain degree of visual restoration.

How to Lay "Safe Tracks" in the "No-Man's Land"?

In the face of the development of innovative medical devices, regulatory innovation is equally crucial.

Currently, no brain-computer interface medical devices have been approved for marketing in China. However, in September this year, the National Medical Products Administration officially released the first brain-computer interface medical device standard, "Terminology for Medical Devices Using Brain-Computer Interface Technology," which differs from the conventional practice of setting standards after products are developed.

"The biggest challenge for innovative products is the lack of available verification methods, evaluation standards, and the like," admitted Liu Xianming, Director of the Medical Device Supervision Department of Zhejiang Provincial Drug Administration. "As a regulatory authority, we must accelerate the development of new tools, new methods, and new standards for supervision."

To this end, the Zhejiang Provincial Drug Administration issued the "Several Measures on Deepening Medical Device Regulatory Reform to Support Innovation in Key Field Medical Devices" in August this year, providing full-process support for the high-quality development of innovations in nine key field medical devices, including medical robots, brain-computer interface medical devices, artificial intelligence medical devices, and high-end medical imaging equipment.

From AI-assisted diagnostics enhancing primary healthcare, to surgical robots making complex surgeries more precise and safer, to brain-computer interfaces bringing new hope to patients with neurological disorders, every breakthrough is the result of a "two-way synergy" between technological innovation and regulatory innovation.

Recently, the Zhejiang Provincial Drug Administration, in collaboration with seven departments, issued the "Implementation Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote High-Quality Development of the Pharmaceutical Industry in Zhejiang Province." Through the integrated coordination of departmental policies, they are fully committed to resolving bottlenecks in the biopharmaceutical industry chain. In the future, the province will continue to deepen the reform of medical device supervision, improve the innovation service system, promote collaborative innovation among government, industry, academia, research, and medicine, and accelerate the transformation and industrialization of scientific and technological achievements. (END)