Begrow Medical's MIAS Ophthalmic Imaging System Receives CFDA Class II Certification and Files IPO Prospectus

Chen Xinjian, Chairman of Bigway Medical Technology, in an Exclusive Interview

VCBeat (WeChat ID: vcbeat) has learned that on December 28, 2018, Bigway Medical Technology successfully held its MIAS new product launch event at the Nikko Hotel in Suzhou. More than 100 doctors, entrepreneurs, investors, and distributors attended the event, including Professor Xu Xun, Director of the Department of Ophthalmology at Shanghai General Hospital; Professor Dai Hong, Director of the Department of Ophthalmology at Beijing Hospital; Mr. He Yuan, Chairman of Hongshang Group; and Mr. Gou Yingqun, Vice President of Wanda Group, who jointly witnessed this exciting moment.

The press conference showcased Bigway Medical Technology’s MIAS 2000, an ophthalmic image storage, processing, and analysis system that has obtained the Class II Medical Device Registration Certificate from the CFDA, while also demonstrating selected features of the fully developed MIAS 3000.

MIAS 2000 is a system designed to assist ophthalmologists in the management, viewing, storage, and transmission of fundus examination image data. Its successful acquisition of the Class II medical device certification from the China Food and Drug Administration (CFDA) marks a significant milestone in Bigwei’s development history. MIAS 3000 is the first dual-modality AI-based ophthalmic product in China, representing the culmination of over 30 invention patents. By integrating color fundus photography and optical coherence tomography (OCT) dual-modality imaging, and leveraging artificial intelligence deep learning technologies, it establishes a cloud-based remote ophthalmic imaging auxiliary diagnosis platform with cloud storage and computing capabilities. Currently, it has achieved AI-assisted diagnosis for dual-modality images (OCT and color fundus photography), enabling the detection of nearly twenty high-prevalence fundus diseases, including diabetic retinopathy, age-related macular degeneration, and glaucoma.

MIAS 3000 automatically provides AI-assisted diagnostic results and quantitative disease analysis reports, achieving an overall accuracy rate of over 96%. Unlike AI systems based solely on color fundus photography, this dual-modality system, which also incorporates OCT-based AI diagnostics, represents a qualitative leap in both the number of diagnosable diseases and diagnostic accuracy. It is poised to become an indispensable auxiliary tool for ophthalmologists in the future.

Applications and Prospects of Artificial Intelligence in Ophthalmology

It is worth mentioning that a roundtable discussion themed “Applications and Prospects of Artificial Intelligence in Ophthalmology” was also held at this press conference. Participants included Professor Xu Xun from Shanghai General Hospital, Professor Dai Hong from Beijing Hospital, Professor Lu Peirong from the First Affiliated Hospital of Soochow University, Professor Chen Haoyu from the Chinese University of Hong Kong–Shantou International Eye Center, Mr. He Yuan, Chairman of Hongshang Group, and Mr. Chen Xinjian, Chairman of Bigwin Medical Technology.

“Cross-disciplinary” collaborations sparked intellectual synergy, with engaging exchanges of ideas proving highly rewarding and exhilarating for attendees. Physicians emphasized that artificial intelligence will become an indispensable assistant in ophthalmology, playing a pivotal role in scientific innovation, clinical diagnosis, treatment outcome follow-up, medical consortium development, and screening systems. With the support of MIAS, ophthalmologists can better unlock productivity and enhance diagnostic efficiency, while primary-care hospitals have significantly strengthened their diagnostic capabilities through MIAS-enabled empowerment.

He Yuan outlined the promising future of MIAS from an investor’s perspective, stating that artificial intelligence will increasingly integrate with various terminal channels to directly serve the general public. This integration aims to enable early detection, prevention, and treatment of eye diseases, while providing comprehensive health management, thereby significantly alleviating the challenges of high healthcare costs and limited access to medical services. Chen Xinjian added that MIAS has already initiated the application process for Class III medical device certification and will maintain a high frequency of product iterations to ensure the delivery of the most up-to-date, accurate, and user-friendly products and services to physicians.

At the conclusion of the press conference, Chen Xinjian, Chairman of Bigway, revealed a special “surprise” by showcasing the company’s latest cutting-edge technology: reconstructing original 2D OCT slices into 3D visualizations, automatically annotating lesions, and generating quantitative analysis reports. In the demonstrated case, the patient presented with seven concurrent fundus disease manifestations, all of which were accurately detected by MIAS. The system displayed 3D visualizations to the physician, with each condition color-coded for intuitive morphological assessment, while providing quantitative metrics such as size and volume. Mr. Chen stated that MIAS has already been adopted in clinical practice at more than thirty hospitals, is projected to reach over 200 institutions next year, and will soon enable ordinary patients nationwide to benefit from this advanced technology in hospital settings.

Bigway Medical Technology is a company specializing in ophthalmic artificial intelligence, founded by a Young Chief Scientist of the National 973 Program and a Gusu Leading Talent. The company’s R&D team consists entirely of individuals holding doctoral and master’s degrees, and it has established an industry-academia-research platform in collaboration with Soochow University. With technological R&D capabilities ranking among the world’s leading, the company has secured dozens of innovative achievements and patents. Guided by its mission to “detect every problematic eye at an early stage and provide the optimal treatment plan,” Bigway Medical Technology is committed to becoming a top-tier international AI company.