Vistel AI Receives NMPA Class III Approval for Diabetic Retinopathy AI Diagnostic Software

Leiphone reports that recently, the diabetic retinopathy fundus image computer-aided diagnosis software (hereinafter referred to as "DR AI") developed by ophthalmic AI company Vistel has officially obtained approval for a Class III medical device registration certificate from China's National Medical Products Administration (NMPA), making it the third medical AI company to secure such certification, following Airdoc and Silicon Intelligence.

According to available data, diabetic retinopathy is relatively common among diabetic patients. The prevalence rate is approximately 5% for those with a diabetes duration of over 3 years, reaches 25% for durations exceeding 5 years, and surpasses 60% for those who have had diabetes for more than 10 years.

Among the large number of affected patients, vision loss in 90% of those with diabetic retinopathy can be prevented through early detection and treatment. However, due to the shortage and uneven distribution of ophthalmologists in China, the vast majority of patients fail to receive early professional screening and diagnostic testing.

Vistel’s recently approved AI product for diabetic retinopathy is primarily designed to identify retinal complications in diabetic patients. It can distinguish and categorize disease severity grades, perform differential diagnosis on fundus images, and determine disease severity. Prior to this approval, the product had already obtained EU CE certification.

Founded in 2016 by Sun Yuhui, former Sales Director of Intel China, Vistel is an artificial intelligence healthcare company specializing in ophthalmic applications.

According to its official website, Vistel's latest funding round took place in March 2019, securing a Series A investment of tens of millions of RMB led by Danlu Capital.

In terms of AI research achievements, it has already accumulated a total of 20 research outcomes and advancements across multiple AI projects based on fundus imaging, slit-lamp examination, OCT, and other modalities.

In addition to the diabetic retinopathy (DR) AI product approved this time, Vistel has also developed a range of products including an AI-assisted diagnostic system for multi-disease fundus imaging, an ophthalmic cloud PACS, and an auto-refractor. Among these, the multi-disease fundus imaging AI-assisted diagnostic product passed approval under the 《Special Review Procedure for Innovative Medical Devices》 in July last year and became the first to obtain EU CE certification in January this year.Leiphone(WeChat Official Account: Leiphone)

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