美國 FDA 核准 AI 裝置 偵測糖尿病造成的眼疾

季晶晶，美國 FDA 核准 AI 裝置 偵測糖尿病造成的眼疾，聯合報 ，2018-04-12

美國食品藥物管理署 (FDA) 周三 (11日) 首度核准利用人工智慧裝置偵測糖尿病引發的眼疾，允許一般醫生診斷患者病情，完全不必解讀數據或影像。 

這種叫做 IDx-DR 的裝置能偵測糖尿病視網膜病變 (Diabetic Retinopathy)，這是美國逾3000萬糖尿病患視力受損的最常見原因。...

以 900 位糖患尿病患眼部影像進行的有效性臨床實驗發現，這種裝置能準確辨識問題比輕度視網膜病變嚴重的機率達 87%，沒有比輕度視網膜病變嚴重者的準確率高達 90%。 

FDA News Release, FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems, April 11, 2018

The FDA evaluated data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites. The study was designed to evaluate how often IDx-DR could accurately detect patients with more than mild diabetic retinopathy. In the study, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4 percent of the time and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5 percent of the time.