Shuimu Jingchuang Assists Yetsea Medical in Securing Class II Medical Device Certification for Its Scanning Laser Ophthalmoscope
Yesight
Ophthalmic Medical Device R&D and Manufacturer
On June 27, CRO platform company Shuimu Jingchuang, under the Zhongguan Village Shuimu Medical Group, assisted Yaoshi (Suzhou) Medical Technology Co., Ltd. ("Yesight") in the independently developed "Laser Scanning Ophthalmoscope."Approved for Class II Medical Device Registration Certificate in China.
In this collaboration with Yesight, Shuimu Jingchuang provides full-process clinical trial services.
The above information is sourced from the website of the National Medical Products Administration.
This Scanning Laser Ophthalmoscope (SLO) isThe First Batch of SLO Equipment to Complete Clinical Trials in China, and has received clinical approval from top ophthalmology hospitals in China such as Beijing Tongren Hospital, Shenzhen People's Hospital, and Guangzhou Aier Eye Hospital. Its performance indicators have reached or even exceeded the standards of imported products, providing a comprehensive and clear display of changes in the fundus. It offers doctors accurate diagnostic evidence, aids in the early detection of blinding eye diseases, and enables continuous monitoring of the condition, therebyOptimize the diagnosis and treatment process, significantly improve the clinical detection rate。And its non-contact design, combined with a safe laser light source, ensuresThe examination process is low-risk, comfortable, and harmless, enhancing the patient's examination experience.Demonstrate China's strength in medical technology innovation and lead the reform in the field of ophthalmic medical devices.
As an ultra-widefield SLO device, this productSingle-shot imaging range reaches 168°, with features such as wide-field fundus imaging, no need for pupil dilation, strong penetration through refractive media, fast imaging speed, and clear images, providing unprecedented convenience and accuracy for fundus examination.
It is worth mentioning that this device adoptsFour-Wavelength Laser (R/G/B/IR)Layered scanning imaging technology, through the depth difference of scanning with lasers of different wavelengths, can fully cover the diagnostic area of the 10-layer tissue structure of the retina at the bottom of the eye, providing doctors with broader, more comprehensive, and deeper clinical information about the eye.
This device was also developed by Yesight.World's First Product Based on Electronic Scanning Mirror TechnologyThe ultra-widefield confocal laser scanning ophthalmoscope, technically achievedA more compact body structure, while possessing greater scalability in performance.。The core components are independently developed, with multiple patented technologies and intellectual property rights, pioneering new technology in the SLO imaging field. The product's portability allows for flexible deployment in remote or inaccessible areas, significantly expanding the reach of medical services and bringing advanced ophthalmic diagnostic capabilities to grassroots medical institutions.Meet the demand of grassroots patients for high-quality ophthalmic examinations, creating a novel and efficient solution for eye health services.
▼Yesight▼
Yesight is a company focusing on innovation in ophthalmic medical devices, integrating the R&D, production, sales of innovative ophthalmic optical platforms, and AI big data research. Its self-developed equipment currently focuses on ultra-widefield confocal laser scanning ophthalmoscopes (Scanning Laser Ophthalmoscope, SLO). The company has a senior technical team with nearly 20 years of experience from Fortune 500 companies and internationally renowned ophthalmic device enterprises, possessing deep expertise in core image processing, optical design, industrialization, and engineering. Production and R&D centers have been established in Suzhou and overseas respectively, based on advanced ophthalmic optical platforms to innovate diagnostic and screening technologies for ophthalmology.
▼Shuimu Jingchuang▼
Shuimu Jingchuang is a CRO platform company under the Zhongguancun Shuimu Medical Group, and is a contract research organization (CRO) specializing in providing professional clinical research technical services to medical device companies.Providing medical device clinical trials, medical writing, global registration, and GMP consulting services for medical device (including in vitro diagnostic reagents) companies.And other professional technical services and one-stop solutions.
Headquartered in Beijing, with branches established in South China, Southwest China, East China, and Northwest China, and personnel dispatched to multiple cities across China, forming a comprehensive service network covering the entire country.
The team is proficient in various clinical trials, registration, and clinical evaluation work both before and after product listing. They have participated in the execution and planning of numerous projects, accumulating rich practical experience. Their areas of expertise include radiotherapy equipment/systems, medical robots, IVD, medical aesthetics, digital therapeutics, and more. They focus on innovative, Class III medical devices produced in China, covering almost all categories, including active, passive, and IVD products. Collaborating with over 200 outstanding clinical research centers across China, they have established a comprehensive service network covering the entire country; they have served more than 200 clients. This has helped achieve several groundbreaking milestones in China's medical device industry.
