Hunan Huoyan Medical Secures First Provincial Ophthalmic Innovative Device Registration with Breakthrough Biometer

In the ophthalmology market, a niche segment is being rapidly captured by domestic innovative forces.

That is the optical biometry sector. This type of instrument is primarily used to measure parameters such as axial length, corneal curvature, and intraocular lens power, and has been widely applied in the fields of myopia control and cataract treatment.

According to incomplete statistics from VCBeat, in the field of myopia prevention and control alone, more than 1,000 optical biometers are sold annually, with rapid growth expected to reach a volume of 10,000 units per year.

However, this vast market has historically been dominated by a well-known foreign brand. In recent years, the wave of domestic substitution and innovation has also swept into the field of optical biometers, particularly those used for myopia control and prevention. In this sector, several competitive domestically produced products have emerged. For example,Recently, Hunan Province issued its first product registration certificate for an innovative ophthalmic medical device.

Huoyan Medical Optical Student Biometer

The products covered by this registration certificate are the Ophthalmic Biometers (Models FAL-5000P and FAL-5000S) developed by Hunan Huoyan Medical Technology Co., Ltd. (hereinafter referred to as “Huoyan Medical”). Adhering to an integrated business development philosophy of “hardware + software + services,” Huoyan Medical’s Ophthalmic Biometer combines three devices—a biometer, an autorefractor, and a keratometer—into a single unit. This integration provides patients with a one-stop testing solution, significantly improving testing efficiency while reducing testing costs.

To date, Huoyan Medical’s ocular biometer (models FAL-5000P and FAL-5000S) has won numerous awards, including the Second Prize at the 7th (2024) China Medical Device Innovation and Entrepreneurship Competition, the Excellence Award in the Hunan Provincial Division of the 6th “China Chuangyi” Entrepreneurship and Innovation Competition, the Second Prize at the 2024 Hunan Innovation and Entrepreneurship Competition, and recognition as a High-Quality Project for Medical Device Innovation and Entrepreneurship at the 13th China Central Investment and Trade Fair.

It should be noted that,Huoyan Medical is a company focused on myopia prevention and control in adolescents, as well as a myopia prevention and control platform that uses biometers as its entry point.

In other words, Huoyan Medical’s product portfolio, including the newly approved ocular biometers (models FAL-5000P and FAL-5000S), is designed for myopia prevention and control. Furthermore,Since its inception, Huoyan Medical has focused on measuring a key indicator in myopia prevention and control: axial length.

Axial Myopia: Axial myopia, the most prevalent form of myopia at present, is characterized by an elongated axial length that exceeds the normal range, while the refractive power of other ocular refractive components, such as the cornea and lens, remains essentially within the normal range.

The "Guidelines for the Prevention and Treatment of Myopia (2024 Edition)" stipulate that regular examinations of children's visual acuity, refractive error, axial length, corneal curvature, and fundus should be conducted starting from kindergarten to establish records of visual and ocular refractive development in children.

In an interview, the founder of Huoyan Medical told VCBeat that previous guidelines for myopia prevention and control did not actually include a mandatory requirement for measuring axial length. The primary reason behind this was the difficulty in widespread adoption due to the high cost of imported equipment at the time. However, with the rise of domestic innovation in the field of ophthalmology, the market for optical biometers has seen an increasing number of Chinese-made products. These devices not only offer a cost-performance advantage but have also achieved breakthroughs in performance.

For example,Huoyan Medical’s first-generation (FAL-1000A) and second-generation (FAL-2000A) axial length meters no longer include preoperative surgical parameters such as lens thickness, anterior chamber depth, and pupil diameter. Instead, they focus on measuring myopia control parameters—namely, axial length and corneal curvature—to increase measurement speed while reducing costs, thereby helping institutions avoid unnecessary expenditures.

Specifically, this series adopts the principle of Michelson optical interferometry to simultaneously acquire axial length and corneal curvature data. Furthermore, characterized by high precision, rapid detection, and ease of use, these devices empower primary healthcare institutions and schools to efficiently conduct myopia screening programs.

It is worth mentioning that,Huoyan Medical’s first-generation product, the FAL-1000A, has also undergone clinical validation at the Eye and ENT Hospital of Fudan University and Beijing Tongren Hospital. Relevant studies indicate that, compared with internationally recognized gold-standard devices, this product demonstrates strong correlation and consistency in axial length measurement, while offering greater speed and convenience in practical operation, thereby facilitating its adoption among non-medical professionals.

Currently, Huoyan Medical's first- and second-generation products have been deployed and are in use at 103 institutions.

Building on its series of axial length measurement products, Huoyan Medical has embarked on a new journey and, after five years of development, launched the aforementioned optometric biometer (models FAL-5000P and FAL-5000S).

 Huoyan Medical Ophthalmic Biometer

According to Li Xiaoping, Co-founder and Deputy General Manager of Huoyan Medical, the Huoyan Medical Ophthalmic Biometer (Models FAL-5000P and FAL-5000S) incorporates multiple innovative technologies. These include automated measurement based on local facial morphology, the integration of multiple optical paths using dual-band light sources and multi-coated beam-splitting prisms, and the innovative consolidation of three distinct devices with different functions and principles—namely, a biometer, an auto-refractometer, and a keratometer—into a single unit.

Among themIntegrating the biometer, computerized refractometer, and keratometer into a single device represents the most significant innovation of Huoyan Medical’s optical biometers (models FAL-5000P and FAL-5000S). This allows patients (users) to complete three previously separate tests in a single session, thereby saving both time and cost. Specifically, with the aid of this device, examination costs are reduced and testing time is shortened compared to conventional methods.

The reduced time per test can, to a certain extent, enhance service efficiency for institutions such as ophthalmic hospitals, optometry centers, and optical stores, thereby driving revenue growth. Meanwhile, “The “three-in-one” design can also save institutions RMB 20,000–40,000 in one-time fixed asset investment.By simultaneously reducing costs and increasing efficiency, Huoyan Medical’s optical biometers (models FAL-5000P and FAL-5000S) are poised to help hospitals, optometry centers, and optical retailers enhance their commercial returns.

It should be emphasized that adopting the “three-in-one” design does not mean a sacrifice in performance. On the contrary,The device features an innovative optical system, novel algorithms, and a high-speed signal processing system, enabling high-precision binocular measurements within 15 seconds. It minimizes errors caused by environmental or other factors during measurements across different devices, thereby further enhancing the accuracy of the measurement data.

Meanwhile, according to the founder of Huoyan Medical, thanks to its innovative optical system design, the product’s footprint is not the sum of three separate devices but equals that of a single unit, making it widely adaptable to diverse settings across various institutions. Furthermore, the device’s fully automated, unmanned operation facilitates easy promotion and adoption in primary care markets.

Therefore, it is not difficult to see that,Huoyan Medical’s Optical Biometer (Models FAL-5000P and FAL-5000S) targets the same market as its previous axial length measurement devices, primarily focusing on the primary care sector. Furthermore, leveraging the established distribution channels of its prior axial length measurement product line, Huoyan Medical’s optical biometer is poised for rapid market entry.

Huoyan Medical’s confidence in its products stems from its R&D team. The company’s research and development members hail from Fudan University and University College London, each possessing at least 15 years of experience in the ophthalmology industry.

Indeed, the rapid development of Huoyan Medical would not have been possible without the strong support of the Hunan Provincial Medical Device Industrial Park.

In 2019, the People’s Government of Xiangtan City, Hunan Province, and the Hunan Provincial Medical Products Administration jointly signed the “Memorandum of Cooperation on Promoting High-Quality Development of the Medical Device Industry,” officially establishing the Hunan Medical Device Industrial Park in the Jiuhua Area of Xiangjiang New Area.

To address the challenges faced by medical device companies, such as "high R&D investment, stringent registration requirements, and prolonged clinical trials," the Hunan Medical Device Industrial Park has leveraged the advantages of its government co-built park model to introduce multiple measures aimed at helping companies overcome these difficulties.

Over the past five years, provincial and municipal policies concerning the medical device industry have been continuously updated and synergistically implemented, fostering integrated institutional innovations in drug regulation, intellectual property, medical insurance, and free trade zones. This has optimized a full-chain ecosystem and platform encompassing intellectual property, clinical research, registration, manufacturing, CDMO services, healthcare institutions, centralized medical insurance procurement, talent development, financial support, technological innovation safeguards, sales, and foreign trade. By leveraging social resources, this approach has cultivated the unique “4+N” advantage characterized by “provincial-municipal co-construction, multi-party participation, synchronized resonance, and integration of industrial chains and clusters.”

For example, to optimize the review and inspection of registration certificates, the Hunan Medical Device Industrial Park has rotated personnel to study at the National Medical Products Administration (NMPA) and the Provincial Medical Products Administration. As professionalization continues to improve, the Hunan Provincial Medical Products Administration established a Xiangtan Sub-center for Review and Inspection, moving review and inspection work forward to enterprises and down to the industrial park, thereby enhancing approval efficiency.

Furthermore, the Hunan Medical Device Industrial Park actively collaborates with the Xiangtan Comprehensive Bonded Zone within the Free Trade Zone to integrate the functions of an export-oriented economic platform with the “decentralization, regulation, and service” reform’s green channel policies implemented by the Hunan Provincial Medical Products Administration. This synergy empowers enterprises to fully leverage international resources and markets, thereby expanding their presence in both domestic and global markets.

With the comprehensive support of the Hunan Medical Device Industrial Park, Huoyan Medical has entered a phase of rapid development. In the future, Huoyan Medical will continue to focus on myopia prevention and control, leveraging its optical biometers as the core technology to launch more screening products tailored to China’s myopia prevention landscape. This initiative aims to achieve high-end intelligent manufacturing of ophthalmic optical biometers and promote domestic substitution.