Artificial intelligence algorithm receives FDA breakthrough device status
January 30, 2020
An artificial intelligence algorithm that can detect a potentially devastating cause of childhood blindness better than most human experts has been granted breakthrough status by the FDA.
The algorithm, called the i-ROP DL system, diagnoses retinopathy of prematurity, or ROP. The algorithm diagnoses the condition in images of infant eyes with comparable or better accuracy than today’s standard method, which involves an examination by expertly trained ophthalmologists.