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Eagle Eye Cataract Detection Independent Medical Device Software Registration Application Approved

 Last Update: 2022-01-22
 Source: Internet
 Author: User

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Article source: Medicine Rubik's Cube Invest

On January 16, 2022, AI medical company Eagle Eye Technology announced that the Shanghai Municipal Drug Administration has approved the company's application for a second-class medical device registration certificate for the company's independent medical device software products for cataract detection

According to the "Supplementary Independent Software of the Good Manufacturing Practice for Medical Devices" issued by the State Food and Drug Administration on July 5, 2019 and implemented on July 1, 2020, independent software refers to one or more medical purposes that do not require medical device hardware.

The announcement shows that Eagle Eye Technology has been approved as an independent medical device software product for cataract detection, which aims to detect early symptoms of cataract by measuring the density of the eye lens

According to the announcement, there will be 151.

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