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AI diagnostic tool plows through FDA clearance, but some experts not convinced

Healthcare IT News: The pivotal trial data that led to the clearance of the first AI-based diagnostic system to not require clinician interpretation was published on Aug. 28 by nPJ Digital.

The 900-patient investigation showed that the IDx-Dr system for autonomous detection of diabetic retinopathy "robustly exceeded the pre-specified primary endpoint goals" and can be realistically deployed and used by non-specialist providers.

"The AI system's primary role is to identify those people with diabetes who are likely to have diabetic retinopathy that requires further evaluation by an eye-care provider," Michael Abràmoff, MD, IDx founder and president, said in a statement.

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