12mm Health Accelerates Certification of China's First Medical-Grade Wearable for Myopia Prevention, Enters Innovation Review Pathway

China is a country with a high prevalence of myopia. According to the latest monitoring data from the National Disease Control and Prevention Administration, the overall myopia rate among children and adolescents in China reached 52.7% in 2023, with trends showing onset at younger ages and increasing severity. In the International Myopia Institute’s “IMI Risk Factors for Myopia” report, experts in optometry and ophthalmology identified risk factors associated with myopia based on research evidence covering seven categories and 25 specific risk factors. The primary factors are educational attainment and time spent outdoors, which demonstrate strong associations and causal relationships with myopia.

However, from a physician’s perspective, data on children’s visual behaviors and visual environments primarily rely on subjective assessment tools such as questionnaires, which are subject to substantial error and limitations and pose challenges for long-term continuous monitoring.The long-standing absence of medical-grade preventive products has left doctors’ interventions for myopia prevention stuck in an awkward situation characterized by qualitative but not quantitative measures.From the user’s perspective, myopia prevention requires a tailored approach for each individual, yet personalized needs have never been adequately met. Consequently, the vast market potential has attracted numerous innovative companies to enter the field, with Twelve Millimeters Health Technology (Hainan) Co., Ltd. (“Twelve Millimeters”) standing out as one of the pioneers.

Shier Millimeters Launches China’s First Smart Wearable Medical Device—Myopia Risk Factor Monitor. This device not only monitors myopia risk in real time but also tracks the implementation of physicians’ intervention plans, establishing a closed-loop management mechanism from monitoring to intervention.

On December 17, 2024, the Myopia Risk Factor Monitor successfully entered Hainan Province’s Special Review Procedure for Innovative Medical Devices. According to Luo Ming, Co-founder and CEO, this innovative deviceNot only does it fill the gap in the myopia prevention and control market for preventive-grade medical devices, but it is also currently the only wearable, medical-grade myopia prevention and control product approved by the National Medical Products Administration (NMPA).This device is designed for recording the visual environments and behaviors of myopic patients or children and adolescents with insufficient hyperopic reserves, aged 4 to 18 years. Based on data collected by the myopia risk factor monitor and outpatient ocular biometric examination results, optometrists analyze the information and issue electronic prescriptions, providing regular reminders and medical interventions for risky behaviors and environmental factors.

Co-founder Zhao Xinlei stated that the Myopia Risk Factor Monitor has achieved multiple technological innovations. The team pioneered the introduction of environmental spectral data analysis technology, which not only captures ambient illuminance parameters but also records key metrics such as color temperature and flicker. Furthermore, leveraging pattern recognition technology, the device can precisely analyze visual behavior parameters, demonstrating robust event analysis capabilities. The application of these technologies has positioned the device at the industry forefront in terms of data acquisition and analysis. Expected to receive regulatory approval in the fourth quarter of 2025, the Myopia Risk Factor Monitor will be the world’s first medical-grade wearable device designed for myopia prevention and control.

Recently, the American Optometric Foundation (AAOF) and Meta Reality Labs Research (RLR) jointly launched a large-scale clinical study. Leveraging Meta’s innovative tool, VEET (Visual Environment Evaluation Tool), the initiative aims to develop visual experience assessment and open data models to advance research into the etiology of myopia. Technical teams on both sides of the Pacific independently developed highly similar designs. The myopia risk factor monitor can be fully benchmarked against Meta’s VEET; however, Twelve Millimeters will achieve regulatory approval and commercial deployment more rapidly.

From the outset of product development, Twelve Millimeters has worked closely with experts in optometry and ophthalmology. These specialists place great emphasis on early intervention, urging parents to begin myopia prevention efforts in children as soon as insufficient hyperopic reserve is detected. However, clinical experts require the participation of technology companies to jointly develop medical-grade devices capable of precisely quantifying and collecting data on visual behavior and visual environments. Such tools help physicians analyze and assess individual risk factors for myopia and provide targeted intervention plans.

In December 2022, Zhong Xingwu, President of Hainan Eye Hospital of Zhongshan Ophthalmic Center, and Ding Hui, Director, reached a consensus with the Twelve Millimeter team and formally signed a three-year cooperation agreement on medical-engineering integration.After 14 months of research and development, the team successfully received the Notice of Acceptance in March 2024; on November 22, it was granted an invention patent by the China National Intellectual Property Administration; and on December 17, it officially received notification of entry into the Innovation Channel.

Luo Ming revealed, “The application materials, spanning over 800 pages, cover multiple stages including product design, manufacturing, and testing, to demonstrate the finalization of the product.” In 2025, Twelve Millimeters will collaborate with clinical experts to apply for key R&D projects in Hainan Province and Haikou City. Additionally, they will jointly submit a national-level project proposal titled “Artificial Intelligence Digital Therapeutics for Myopia Prevention and Control” in partnership with the Zhongshan Ophthalmic Center, Hainan Eye Hospital, Haikou People’s Hospital, and Hainan University.

Unlike traditional digital therapeutics, which primarily rely on software-based intervention programs,The 12-mm product is a comprehensive system, comprising intelligent wearable hardware, an AI-assisted decision-making and analysis central station, AI-based digital therapeutics, as well as mini-programs and mobile apps.This closed-loop product, which integrates hardware and software with artificial intelligence technology, forms a complete chain from monitoring to analysis, and then to intervention and prevention.

“Myopia Risk Factor Monitor” is an innovative product that combines both consumer-grade and medical-grade attributes.

As a smart wearable device, it targets ordinary consumers; meanwhile, its data analytics system can also serve medical institutions, enabling Twelve Millimeters to adopt a market strategy that blends the dual characteristics of traditional medical devices and internet consumer goods. In terms of marketing, the company employs a diversified channel strategy: online, it collaborates with major e-commerce platforms, while offline, it penetrates through specialized medical consortia and health-management ecosystems. This approach allows the product to deliver consumer healthcare services with the quality standards of serious medical care.

To accommodate diverse application scenarios, Twelve Millimeters will continue to develop the Myopia Risk Factor Monitor 2.0 and other related product lines, specifically tailored for children with insufficient hyperopic reserve, children wearing orthokeratology (OK) lenses, and children wearing defocus spectacles. In terms of production capacity planning, the team has adopted a flexible “in-house manufacturing + contract manufacturing” model. It is projected that within the next one to two years, the company will be able to meet market demand at the scale of millions of units. In addition to the domestic market, the Twelve Millimeters team began expanding into overseas markets this year. The international patent application number is PCT/CN2023/138141; notification of entry into the national phase was received on January 14, 2025. The team is concurrently pursuing overseas patent protection and regulatory approvals.

In the future, Twelve Millimeters will focus its strategic efforts on the industrialization and commercial implementation of its R&D outcomes. To this end,The team leverages artificial intelligence as its core breakthrough, enhancing physicians’ diagnostic and treatment efficiency through AI-assisted analysis and decision-making capabilities.According to estimates, the introduction of AI technology can increase physicians’ service efficiency by a factor of 100 to 1,000, which will not only help expand the coverage of medical services but also drive intelligent upgrades in the field of myopia prevention and control.