iPredict - Automated retinopathy analysis system application software

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Arif Systems

Class:

Class IIa

Manufactured by:

iHealthScreen Inc 132-2 89th Avenue Suite 214, Richmond Hill, NY, 11418 United States Of America

Therapeutic area:

58713 - Automated retinopathy analysis system application software

Therapeutic indications:

The software tool iPredict, will automatically screen individuals at risk of developing diabetic retinopathy (DR), age-related macular degeneration (AMD), and Glaucoma in the Primary Care and other clinical settings. An individual software application program or group of programs is used in combination with one or more retinal imaging devices, such as a fundus camera, for either point-of-care or remote (telemedicine) use. The software provides analysis capabilities for the detection of retinopathy and other retinal diseases for early diagnosis and management in patients at risk, to prevent further deterioration and visual loss. A basic set of programs are included with such systems and can be automatically or manually upgraded to correct programming errors or to add new system capabilities. It may also be used in an off-the-shelf desktop, laptop, or tablet computer.

Authorization status:

A

Authorization date:

2022-02-11