Pivotal trial of a deep-learning-based retinal biomarker (Reti-CVD) in the prediction of cardiovascular disease: data from CMERC-HI.
The potential of using retinal images as a biomarker of cardiovascular disease (CVD) risk has gained significant attention, but regulatory approval of such artificial intelligence (AI) algorithms is lacking. In this regulated pivotal trial, we validated the efficacy of Reti-CVD, an AI-Software as a Medical Device (AI-SaMD), that utilizes retinal images to stratify CVD risk.
Author(s): Lee, Chan Joo, Rim, Tyler Hyungtaek, Kang, Hyun Goo, Yi, Joseph Keunhong, Lee, Geunyoung, Yu, Marco, Park, Soo-Hyun, Hwang, Jin-Taek, Tham, Yih-Chung, Wong, Tien Yin, Cheng, Ching-Yu, Kim, Dong Wook, Kim, Sung Soo, Park, Sungha
DOI: 10.1093/jamia/ocad199