iHealthScreen cleared a crucial FDA hurdle, but can iPredict-DR break AI eye screening’s adoption barrier?
iHealthScreen’s FDA-cleared iPredict-DR brings automated diabetic retinopathy screening closer to primary care, but adoption hurdles remain.
Medical Devices & Diagnostics
Medical Devices & Diagnostics
What iHealthScreen’s iPredict-DR clearance changes for diabetes clinics and primary care
iHealthScreen Inc. has received U.S. Food and Drug Administration 510(k) clearance for iPredict-DR, an AI-powered Software as a Medical Device for automated diabetic retinopathy screening. The retinal imaging software detects more than mild diabetic retinopathy in adults with diabetes who have not previously been diagnosed with the condition, placing the healthcare AI developer into a