Vistel's Multi-Disease AI Ophthalmic Diagnostic Software Receives NMPA Approval

Jun 19, 2024 17:31 CST Updated 17:31

Vistel

Artificial Intelligence Eye Health Product Developer

Today (June 19), the National Medical Products Administration announced that it recently approved the registration application for the innovative product "Fundus Lesion Fundus Image Auxiliary Diagnosis Software" produced by Vistel.

The First Fundus Image Assisted Diagnosis Software Designed Based on Multi-Disease Algorithms

The fundus lesion fundus image auxiliary diagnosis software includes a client side and a server side. The server-side software consists of a user registration and login module, a patient information management module, an image automatic analysis module based on deep learning algorithms (including an image quality assessment module and a multi-disease recognition module for fundus), a report generation and management module, and a system management module.

This product is the first retinal image-assisted diagnostic software designed based on a multi-disease algorithm. Compared with single-disease algorithms, this product uses a single network model to determine whether there are any abnormalities in the fundus and then identifies various common retinal diseases.

This product can assist doctors in conducting comprehensive examinations for various fundus diseases. Compared with single-disease auxiliary diagnostic products, it has a wider application scope and can further enhance the diagnostic capabilities of common fundus diseases in primary medical institutions, prompting a broader population to receive early examination and treatment, reducing the occurrence of vision impairment and blinding diseases, and alleviating the social burden brought by related diseases.

On July 11, 2023, the Center for Medical Device Evaluation of the National Medical Products Administration released the results of the special review application for innovative medical devices (No. 5 of 2023), proposing to approve nine medical device projects to enter the special review process. Among them is Vistel's retinal image-assisted diagnostic software.

Focusing on Ophthalmology, Dedicated to Exploring Artificial Intelligence Technology

Vistel (Beijing Zhiyuan Huitu Technology Co., Ltd.) was established in 2016. It is a high-tech enterprise dedicated to exploring the application of artificial intelligence (AI) technology in the medical industry, particularly in the field of ophthalmology. Vistel has China's top medical imaging AI laboratory, which currently includes numerous PhDs and master’s degree holders specializing in medical imaging research (from Tsinghua University, Renmin University, National University of Singapore, Northwestern Polytechnical University, etc.). The technical team has deep expertise and industry experience in areas such as computer vision processing, artificial intelligence, image annotation, and big data computing. Through collaboration with ophthalmology medical teams, Vistel provides AI-driven solutions along with smart ophthalmic hardware for disease screening, diagnosis, and treatment.In August 2021, Vistel announced the completion of a nearly 100-million-yuan Series B financing round.

As a leading enterprise in the AI healthcare industry, since 2016, Vistel has been collaborating with more than ten top ophthalmology teams in China, such as Peking Union Medical College Hospital, Beijing Tongren Hospital, and Beijing Hospital. Relying on the "integration of medicine and engineering" development approach, Vistel has continuously advanced artificial intelligence research in eye health. To date, dozens of papers have been selected for top international conferences and journals like MICCAI and BMVC, with several research achievements making academic breakthroughs.

Vistel Diabetic Retinopathy Auxiliary Diagnosis Software Interface

Currently, Vistel's AI-related technical achievements for diabetic retinopathy have been transformed into products.And it has been officially approved by the China National Medical Products Administration (NMPA) as a Class III medical device. The clinical trial results showed a sensitivity of 92.96% and a specificity of 93.32%, demonstrating outstanding performance among similar software globally.

In response to the complex and diverse needs of eye disease diagnosis and treatment at the grassroots level, the multi-disease fundus image auxiliary diagnosis software developed by Vistel is able to assist in diagnosing more than ten common blinding eye diseases based on fundus color photos, including diabetic retinopathy, age-related macular degeneration, glaucoma, and retinal vein occlusion.This software is the first artificial intelligence-assisted diagnostic software to pass the review and approval (Class III) of the "Special Review Procedure for Innovative Medical Devices," and it ranks at a globally leading level in terms of the number of covered diseases and diagnostic accuracy.

As of now, 273 innovative medical device products have been approved for marketing in China.

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