Airdoc and Zhongshan Ophthalmic Center Receive Class II Medical Device Certification for AI-Powered Cataract Detection Software

Source: China Network Technology

On January 16, Airdoc announced that its cataract detection standalone medical device software (SaMD) product, jointly developed with Zhongshan Ophthalmic Center, Sun Yat-sen University, has been approved for a Class II Medical Device Registration Certificate (Shanghai Approval No. 20222210002) by the Shanghai Medical Products Administration. This is the second standalone SaMD product for ophthalmology clinics that Airdoc has received approval for following its glaucoma detection product. It will effectively address the limitations of traditional cataract diagnosis and make significant contributions to China's cataract prevention and treatment efforts as well as the improvement of national eye health standards.

Diagnosis Rate Less Than 30%

Cataract Detection Methods Need to Change

With the development of the economy and society, as well as the intensification of population aging, visual impairments caused by eye diseases such as cataracts, glaucoma, and diabetic retinopathy seriously affect people's physical and mental health and quality of life, increasing the burden on families and society. According to Frost & Sullivan, the number of cataract patients in China reached 152 million in 2020, and it is expected to increase to 238 million by 2030. However, the diagnosis rate for cataracts in China was less than 23% in 2020.

As a common ophthalmic disease, cataracts are characterized by lens opacity and result in decreased vision. Currently, cataracts are primarily diagnosed by doctors using a slit-lamp microscope and are graded according to established clinical grading standards. However, this diagnostic method relies on manual detection by ophthalmologists, which is not only time-consuming but also requires substantial experience. Consequently, manual diagnosis of cataracts faces significant challenges in rural areas where there is a shortage of well-trained ophthalmologists. Additionally, subjective grading is inevitably influenced by human factors, and the grading results may vary among different ophthalmologists, leading to less-than-ideal diagnostic outcomes.

With the increasing burden on ophthalmology outpatient services, there is an urgent need for an automated, efficient, and high-performance cataract detection method to address the limitations of existing cataract detection approaches.

The product has multiple advantages.

Promoting High-Quality Development of Eye Health During the "14th Five-Year Plan" Period

The "14th Five-Year Plan" for National Eye Health in China (2021-2025), recently released by the National Health Commission, pointed out that China remains one of the countries with the largest number of blind and visually impaired patients in the world. The total amount of high-quality ophthalmic medical resources in China is still relatively insufficient, and the problem of uneven distribution persists. The capacity for eye health services at the grassroots level still needs to be strengthened, and the tasks for eye health work remain arduous.

Zhongshan Ophthalmic Center, Sun Yat-sen University, in collaboration with Airdoc and four other institutions, jointly undertakes the key national R&D program "Research and Development of Digital Medical Equipment," aiming to address AI-based screening, diagnosis, and treatment of major blinding, disabling, and life-threatening diseases. The recently approved SaMD product for cataract detection is also one of the significant achievements of this key project.

The product aims to detect cataracts by measuring the color values of various structures in the eye's lens and correlating these values with the internationally recognized Lens Opacities Classification System III (LOCS III) for cataract grading, thereby identifying cataracts that require referral based on severity. The product offers advantages such as ease of use and accurate detection, enabling medical personnel to detect cataracts in a standardized and quantifiable manner through quantitative measurements of the lens, and to grade them accordingly.

Project leader, Professor Lin Haotian, Deputy Director (Deputy Dean) of Zhongshan Ophthalmic Center, Sun Yat-sen University, conducts cataract detection.

Project leader Professor Lin Haotian, Deputy Director (Deputy Dean) of Zhongshan Ophthalmic Center, Sun Yat-sen University, is committed to improving the diagnosis and treatment of diseases through technology, especially blinding eye diseases. He stated: "This cataract detection SaMD product not only shortens the diagnosis time to 2-3 minutes, greatly improving diagnostic efficiency, but also is very easy to operate. Medical staff can use it after simple training, making it suitable for promotion at the grassroots level where ophthalmic resources are relatively scarce, benefiting more patients."

Airdoc founder Dailei Zhang said: "Eye diseases such as cataracts, glaucoma, and diabetic retinopathy have become major blinding eye diseases in China and have also been listed as key prevention and treatment targets in the '14th Five-Year Plan' for national eye health in China. The approval of this cataract detection SaMD enables Airdoc to join the forces in cataract prevention and treatment. We will continue to uphold the principle of inclusiveness, adhere to professionalism, stay committed to long-termism, strengthen the transformation of R&D results, and continuously undergo clinical trials and product compliance approvals, striving to make quality healthcare services accessible to more people."

All the above images are provided by Airdoc and authorized for use by China Network Finance.