Shots:
- The US FDA has granted 510(k) clearance to iPredict-DR, an AI-powered software that automatically detects more than mild diabetic retinopathy (mtmDR) in adults with diabetes who have not been previously diagnosed
- iPredict-DR uses AI to analyze retinal fundus images from the iCare DRSplus camera for non-invasive & affordable diabetic retinopathy screening, with clearance backed by a clinical validation study evaluating its diagnostic performance, safety, & usability
- Commercially available across the US, the company is advancing iPredict-DR for age-related macular degeneration, glaucoma, hypertensive retinopathy, & CV disease risk while pursuing commercialization & distribution partnerships
Ref: Businesswire | Image: iHealthScreen | Press Release
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