iHealthScreen Receives U.S. FDA 510(k) Clearance (K253704) for iPredict-DR, an AI-Powered Software for Automated Diabetic Retinopathy Screening
iHealthScreen, Inc., a healthcare AI company developing Software as a Medical Device (SaMD) for retinal and cardiovascular disease screening and preventive healthcare, today announced FDA 510(k) clearance (K253704) for iPredict-DR™, its AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes not previously diagnosed with the condition.
