Two medical devices have entered the priority approval channel

January 9, 2025  Source: drugdu 110

"/According to the China Medical Device Innovation and Priority Approval Database, in December 2024, two medical devices entered the priority approval green channel in public announcements issued by local drug regulatory authorities across the country. They are: the disposable electronic endoscopic thoracoscopic laparoscopic catheter from Fujian Zhide Medical Technology Co., Ltd. (hereinafter referred to as Fujian Zhide), and the cognitive impairment assisted diagnosis and rehabilitation software from Hainan Boya Health Technology Co., Ltd. (hereinafter referred to as Hainan Boya).

Fujian Zhide: Focusing on Endoscopy
Fujian Zhide was established in April 2022 and is a company dedicated to the research and manufacturing of electronic endoscopic medical devices. The disposable 4K electronic endoscope technology developed by the research and design team of Fujian Zhide Optics has received widespread attention. This technology is both safe and convenient, not only greatly reducing the infection rate and improving cost-effectiveness, but also adapting to grassroots needs.

Entering 2025, Fujian Zhide also welcomed a "good start". On January 4th, Fujian Zhide officially announced that its medical device products have successfully obtained the Medical Device Registration Certificate from the National Medical Products Administration (NMPA), covering its two core products - medical endoscopic image processors and disposable electronic bronchoscopy catheters.

It is reported that disposable electronic bronchoscopy catheters have multiple characteristics:
 Clear Image: Provides clear and accurate endoscopic images to help doctors make more precise diagnoses. The front end adopts a micro CMOS camera and dual LED light source design, with a 120 ° field of view and a depth of 3-100mm, providing clear surgical vision for the surgeon;
 Efficient bending: The front end keel is bent up and down 180 degrees, with strong bending ability, allowing the insertion part to easily enter more bronchi, facilitating more diagnosis and treatment for the surgeon;
 No cross infection: one mirror per person, no need for disinfection and sterilization, to prevent cross infection.
 The medical endoscope image processor adopts a self-developed image sensor module, combined with image processing technologies such as white balance and noise reduction, which can significantly improve image clarity, ensure that the edges of the field of view are not blurred, and enhance diagnostic accuracy. In addition, the product also has multifunctional interfaces that can be compatible with various endoscopic devices to meet different medical needs. Moreover, it has the ability to operate continuously and efficiently, supporting functions such as photography, video recording, and image freezing, ensuring stability during the surgical process, and can fully record key information.

Boya: Dedicated to the research and development of brain computer interaction applications
Hainan Boya was established in August 2024 and is a subsidiary of Jiangsu Boya Technology Co., Ltd. (hereinafter referred to as Boya Technology). Boya Technology is a high-tech enterprise dedicated to the research and development of brain computer interaction applications. Based on the integration of cutting-edge theoretical research results in neuroscience, neuroscience, and psychology, it constructs a product matrix in the field of cognitive neuroscience from early screening to intervention through digital modeling, AI algorithms, and brain computer interaction technology, providing intelligent solutions for brain health for all age groups.

In October 2024, Boya Technology launched a heavyweight product - the Blue Walnut Brain Computer Interaction System. This system is the first brain computer interaction system in China that can achieve efficient and accurate screening and intervention training for depression and cognitive impairment. It is a non-invasive brain computer interface system.

It is reported that the Blue Walnut Brain Computer Interaction System integrates EEG signal acquisition, monitoring, compilation, and intervention. It has formed a mature solution in EEG signal acquisition, processing, and decoding, and has multiple unique advantages in EEG acquisition, signal decoding, and other aspects:
 High precision ultra flexible graphene electrodes help improve the quality of EEG signal acquisition and detection accuracy. They can detect weak electrical signals generated by neuronal discharges, decode and determine individual intervention plans, and monitor feedback effects;
 Ergonomic design, stretchable structure and elastic material keep it in perfect position on the head, adjustable and flexible, safe and healthy materials inside, better fitting the head shape, while the support frame has slight flexibility to adapt to different ear contours;
 Innovative intelligent analysis algorithm, using exclusive real EEG map analysis+cognitive emotion indicators, real-time collection and analysis, enabling the system to more accurately evaluate brain health level, output screening results within 3-5 minutes, with an accuracy rate of over 90%;
 Equipped with the Blue Walnut Cognitive Assessment and Training System, this system utilizes technologies such as artificial intelligence, digital modeling, and brain computer interaction to analyze multidimensional data and develop personalized brain health digital solutions for different populations.

In addition, in addition to the Blue Walnut Brain Computer Interaction System, Borya Technology has also launched the Blue Walnut Brain Computer Interaction Head Ring and Blue Walnut Cognitive Evaluation and Training System, which target the needs of different groups, achieve precise and efficient screening, and improve the professional cognitive abilities of the system.

Over the years of accumulation, Borya Technology has developed a one-stop non-invasive brain computer interface system that has evolved from cognitive screening and training to efficient data analysis systems and norm database processing platforms. This system provides scientific and professional means and methods for safeguarding brain health and cognitive neural health, leading a historical transformation in cognitive screening and intervention training.

Conclusion
With the support of policies and the promotion of continuous technological development, the "gold content" of domestic medical devices is becoming increasingly high, and local medical devices are continuously shining with new brilliance.

Source: https://news.yaozh.com/archive/44778.html

By editor
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