Boshi Medical's ZhiGuang®: China's First AI-Powered, Smart Navigation Retinal Laser Photocoagulator Receives NMPA Approval

Aug 26, 2024 09:14 CST Updated 09:14

Robotrak Technologies

Ophthalmic Medical Device R&D Developer

Source: Eye Future; Editor: Bai Xiaofei

Reprint requirements: Can be reprinted 24 hours after the first publication, source must be credited.

Recently, information released on the official website of the National Medical Products Administration shows,Robotrak Technologies Co., Ltd.Independently Developed Innovative Products"RankLight® Intelligent Retinal Navigation Laser"OfficialApproved by NMPA for Class III Medical Device Registration Certificate (Registration No. 20243161449). Up to now, the company has independently developed a number of advanced devices,A total of 4 medical device product registration certificates have been approved.。

Ranklight®Intelligent Navigation Laser for Fundus is aOphthalmic All-Solid-State Laser Photocoagulator, alsoThe First Product in ChinaLaser treatment equipment with innovative features such as real-time high-definition wide-field imaging, high-speed eye-tracking, artificial intelligence surgical assistance planning, and precise automatic laser.This product is mainly used for laser photocoagulation treatment of fundus diseases., such as diabetic retinopathy, central serous chorioretinopathy, retinal holes, retinal degeneration, macular edema, etc.

In March 2024, Robotrak Technologies' ophthalmic semiconductor laser photocoagulator ——Chengguang®Has also successfully obtained the Class III Medical Device Registration Certificate issued by the National Medical Products Administration, officially launched.。This product is a 577nm laser system with micropulse functionality, marking a breakthrough for domestically produced equipment in the 577nm micropulse laser field, and representing an important step for China-produced ophthalmic medical devices to align with cutting-edge international technology.

At the same time, Robotrak Technologies was also awarded by the Science and Technology Department of the Ministry of Industry and Information Technology and the Medical Device Registration Department of the National Medical Products Administration.Winner of the Artificial Intelligence Medical Device Innovation Task”，Its "Ophthalmic All-Solid-State Laser Photocoagulator" (RankLight® Intelligent Retinal Navigation Laser）Successfully Selected"Intelligent Auxiliary Treatment Product"。

# ProductMarket Prospects

Fundus Diseases IncludeNeovascular Age-Related Macular Degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), dry eye disease, glaucoma, etc., with nAMD being predominant among the elderly.

According to Evaluate Pharma statistics,Fundus diseases are the fastest-growing market in the field of ophthalmology., the market size was approximately 21.8 billion US dollars in 2021. Among this,nAMD, DME, and RVO account for the largest market share., accounting for 63%. In 2020, nAMD, DME, and RVO were approximately USD 12.928 billion, contributing USD 7.8 billion, USD 3.12 billion, and USD 2 billion respectively.Expected to grow to USD 8.76 billion, USD 3.86 billion, and USD 2.4 billion respectively by 2025。

In addition,The significant increase in the elderly population has led to a rise in age-related macular degeneration and diabetes, contributing to an increase in eye-related discomfort and diseases.。In additionThe application of information technology in the healthcare industry, high investment, the rising prevalence of target diseases such as diabetes, age-related eye diseases, and technological advancements in the medical device field,Are all driving the development of the ophthalmic photocoagulator market.。According to the research data from Bezhes Consulting,2The global ophthalmic photocoagulator market size reached US$ 290 million in 2024 and is expected to have a CAGR of 4.3% from 2024 to 2029.

Laser Treatment for Fundus Diseases, or Retinal Photocoagulation,By utilizing the thermal effect of lasers, it targets abnormal retinal tissue, seals leaking retinal blood vessels, and inhibits the growth of new blood vessels., slowing down the metabolism of pigment epithelial cells, creating scar adhesions between the retina and the pigment membrane to prevent retinal detachment. Lasers with longer wavelengths can cause atrophy of choroidal tumors, thereby stabilizing or improving existing vision, reducing the risk of deterioration, preventing complications, etc., achieving the purpose of treating fundus diseases.

Due toThe semiconductor laser has strong penetrability, and the refractive medium absorbs it the least., The main indications currently used in clinical applications include various types of glaucoma, vitreoretinal and choroidal diseases, refractory glaucoma, choroidal melanoma, and choroidal neovascularization. Researchers have applied semiconductor lasers with a wavelength of 810nm and an output power of 1750~3000mW to treat post-penetrating keratoplasty glaucoma.Clinical validation showsThe energy required for semiconductor laser to penetrate the sclera is lower, and the energy can be better absorbed by melanin., without causing thermal damage due to excessive energy absorption by the refractive media.。

Another study used semiconductor lasers with output powers of 1000~3000mW and 500mW, respectively, to treat multiple cases of refractory glaucoma patients, and evaluated their clinical efficacy and safety. The results showedTransscleral cyclophotocoagulation with semiconductor laser is a simple, minimally painful, safe, and effective method for treating refractory glaucoma.。

# OrderLight® Intelligent Retinal Navigation Laser

RankLight® Intelligent Retinal Navigation Laser

The main application of RankLight® Intelligent Retinal Navigation Laser isLaser Photocoagulation Treatment for Fundus Diseases. The product adopts advancedReal-time Image Acquisition Technology, makingDoctors do not need to rely on traditional slit-lamp microscopes., allowing direct observation and capture of real-time ultra-wide-angle fundus images through the screen.

Doctors can base their diagnosis on fundus photographs or images from other diagnostic devices,Perform AI-Assisted Digital Treatment Planning, including the location of laser treatment, spot size, interval, and protection zones, etc. Combined with high-speed eye-tracking and intelligent navigation technology,The device is able to directly guide the laser to the preset position., achieving intelligent, rapid, and preciseAutomatic Laser Treatment。

The RankLight® Intelligent Retinal Navigation Laser not only addresses multiple pain points of traditional slit-lamp laser treatment, but also featuresIntelligence, Speed, and PrecisionSignificant advantages such as...

With the integration of 5G technology, the device can also achieveRemote Laser Therapy，Contributes to the further下沉 of retinal laser photocoagulation technology, improving the accessibility of high-quality medical resources in China, benefiting tens of millions of patients with fundus diseases.

# Comparison of Products in the Same Track

Product Name：YELLOW LASER PHOTOCOAGULATOR YLC-500

Applicant CompanyNidek Co., Ltd.

FDA Approval Date：2017-6-23

Classification Code: HQF (Ophthalmic Laser)

Registration Certificate Number：China Medical Device Registration No. 20203160198

YLC-500 Ophthalmic Semiconductor Laser Photocoagulator

The product adoptsYellow Laser, the power output surges momentarily, then remains stable, and finally decreases instantaneously, thereby achievingFast, High-Power Laser EmissionThe scanning mode. Compared with the 532nm laser,577nm yellow laser is barely absorbed by lutein but can be well absorbed by oxyhemoglobin., which makes itBecoming the preferred wavelength for treating lesions near the macula。

Nidek's laser surgical equipment is divided into two major categories: laser photocoagulators and anterior segment laser systems. There are three types of photocoagulators: the dedicated green laser photocoagulator GYC-500, the dedicated yellow laser photocoagulator YLC-500, and the MC-500 which supports three wavelengths simultaneously.

Product Name：Green Laser Photocoagulator GYC-500

Applicant CompanyNidek Co., Ltd.

Approval Date：2016-5-2

Classification Code: HQF (Ophthalmic Laser)

Registration Certificate Number: China Medical Device Registration Import 20203160197

GYC-500 Ophthalmic Laser Photocoagulator

GYC-500 Ophthalmic Semiconductor Laser Photocoagulator features a sleek and compact design, being lightweight and portable. It can be mounted on a stand, allowing for easy movement to any room.

AdoptGreen Solid-State Laser，Ensure Stable Laser Output. Equipped withTwo cooling fans to maintain stability during long working hoursA 5.7-inch color LCD touchscreen console allows for quick and easy setup and verification of scanning templates and treatment parameters through an intuitive graphical user interface.

Product Name：Vitra 2

Applicant CompanyQuantel Medical

Approval Date：2019-12-5

Classification Code：GEX (Active Laser Surgical Device)

Registration Certificate Number: China Medical Device Registration Import 20203160484

Vitra 2 Laser Photocoagulator

Vitra 2 Laser Photocoagulator Adopted532nm Green Laser, the laser photocoagulator can provideA More Stable Laser Source, for photocoagulation treatment of secondary cataracts of the anterior segment, diabetic retinopathy, retinal neovascularization and hemorrhage, retinal hemangioma, choroidal hemangioma and other diseases.

Products includeMultiple transmission modes available, compatible with various adapters., can be upgraded to an integrated anterior-posterior laser, compact in size for easy transport, with adjustable aiming beam intensity, fully enclosed laser cavity for longer service life.

# Company Profile

Robotrak Technologies Co., Ltd. was established in 2017 as a First-in-ClassOphthalmic Innovation for All AgesPlatform-based company, dedicated toScreening and Treatment of Fundus Diseases, adolescent myopia prevention and control, functional contact lenses, ophthalmic digital healthcare, customized research equipment, and other globally leading solutions.

The company possesses core technologies such as adaptive optics, optical design and precision machining, optical measurement and imaging, eye tracking, precise laser positioning, artificial intelligence, image algorithms, and material processes.Building Two Major Business Segments: Ophthalmic Equipment and Contact Lenses, Covering Medical, Consumer, and Research Markets。

In addition to the ophthalmic semiconductor laser photocoagulator, Robotrak Technologies Co., Ltd. also hasStellarLens® Adaptive Optics Retinal Imaging System(Su Medical Device Registration Approval 20242160025), isThe World's FirstCommercial-grade non-invasive high-resolution retinal imaging system based on AO-SLO technology; andA Multimodal, High-Resolution, Ultra-Widefield Ophthalmic Imaging Research Instrument Specifically for Small Animals——Haojing® Small Animal Multi-Modal Ophthalmic Imaging System, has also been successfully launched and delivered.

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