Vistel Secures CE Certification for Its Ophthalmic AI Diagnostic Product Amid IPO Filing
Vistel
Artificial Intelligence Eye Health Product Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Leiphone(WeChat Official Account: Leiphone)News: In January 2020, Vistel’s AI-powered ophthalmic medical product received CE certification from the European Union. This marks the second domestically developed medical AI product to obtain EU certification in recent times.
Currently, the EU is in a transitional phase between the old and new regulatory standards for CE certification (MDD and MDR), with the new MDR set to be implemented this May. Vistel’s products have now obtained CE certification, enabling their widespread adoption across EU member states at least one year ahead of schedule.
Fundus diseases are a significant risk factor threatening human vision, particularly diabetic retinopathy. According to the official website of the International Diabetes Federation (IDF), approximately 463 million adults aged 20–79 worldwide had diabetes in 2019, with the prevalence in Europe increasing at an annual rate of 15%. About 25% of patients with diabetes develop retinopathy, which can lead to blindness in severe cases. Early screening and diagnosis can reduce the risk of blindness by 94.4%.
In 2017, Vistel AI Laboratory collaborated with domestic ophthalmology expert teams to jointly develop artificial intelligence products for ophthalmology. Over the past three years, it has continuously collected high-quality multi-center fundus image data and annotated nearly one million fundus images using professional annotation tools. This enables the provision of more timely and effective intelligent screening services for patients with fundus diseases, particularly those with diabetic retinopathy. Currently, these solutions have been implemented in hundreds of medical institutions both domestically and internationally, serving nearly one million patients.
Beijing Vistel Technology Co., Ltd. (Vistel), established in 2016, is a high-tech enterprise dedicated to exploring the application of artificial intelligence (AI) in the healthcare industry, particularly in the field of ophthalmology. Vistel boasts a top-tier medical imaging AI laboratory in China, which currently employs more than 20 PhD and Master’s degree holders specializing in medical imaging research, graduating from prestigious institutions such as Tsinghua University, Renmin University of China, National University of Singapore, and Northwestern Polytechnical University.
As of February 2020, Vistel had obtained eight software copyrights and 20 patents, published 12 research papers in internationally renowned professional journals or conferences, and another collaborative achievement with Peking Union Medical College Hospital was soon to be published in an authoritative journal.
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