Medical device developer MiiS’ AI-DR granted Class II clearance by TFDA


Medimaging Integrated Solution (MiiS) announced that its proprietary AI-DR (Diabetic Retinopathy), a software for retinal image analysis, has now been cleared by Taiwan’s FDA as Class II medical device.

According to MiiS, AI-DR is the world's first AI-powered software that identifies DR by types, stages and lesions- all at the same time. This software outweighs the existing products in terms of sensitivity (over 98%) and specificity (over 96%), helping general physicians monitor DR development in patients, locate the lesion and refer patients to eye doctors whenever necessary.   

AI-DR integrates hardware and software, which is compatible with six branded desktop fundus camera systems commonly used in hospitals and handheld imaging devices of other brands. AI-DR can enhance efficiency and capacity of telemedicine and early detection of diabetic eye complications particularly.

MiiS is also applying AI to wound care through mobile phones, having developed a wound care system that allows nursing staff to view and show the size of wounds after taking pictures of patients, check wound inflammation and keep nursing records. This wound-care system is expected to be TFDA-cleared by 2022.

Founded in 2010, MiiS started with the development of fundus cameras and has since launched handheld medical devices for the ear, nose, mouth and skin. Images taken by MiiS’ handheld medical imaging products are of high quality and high-definition, can be sent with image details preserved. Going forward, the company will be developing precision medicine as well as in vivo devices such as disposable endoscopes.