Diabetic Retinopathy Diagnostic Software with Fundus Photograph

On August 10, 2020, NMPA approved the registration of two “Diabetic Retinopathy Diagnostic Software with Fundus Photograph” produced by SiBionics and Airdoc respectively. Though the name of the two products are the same,the product compositions and intended uses of them are slightly different. For example, product of SiBionics can be applied for the analysis of binocular color fundus images in adult diabetic patients while product of Airdoc can be used for the analysis of binocular color fundus images of FREE DILATED EYES in adult diabetic patients. Currently, no predicate has been approved in China.

Link: https://www.nmpa.gov.cn/yaowen/ypjgyw/20200810093435157.html