Overview
- iHealthScreen has received FDA 510(k) clearance for iPredict-DR™, an AI-powered tool for detecting more than mild diabetic retinopathy.
- The software is designed to support accessible retinal screening in primary care and underserved healthcare settings.
- The clearance marks iHealthScreen’s first commercial milestone as it expands its AI-powered screening portfolio.
The News
iHealthScreen announced FDA 510(k) clearance for iPredict-DR, an AI-powered Software as a Medical Device designed to automatically detect more than mild diabetic retinopathy in adults with diabetes who have not previously been diagnosed with the condition.
The software analyzes color retinal fundus images captured using the iCare DRSplus camera and is designed for use by minimally trained healthcare workers or nurses. By supporting screening outside specialist eye care settings, iPredict-DR aims to improve access to early detection and referral, particularly in primary care and underserved communities. The clearance was supported by a clinical validation study evaluating the software’s diagnostic performance, safety, and usability.
Industry Perspective
Diabetic retinopathy can progress without noticeable symptoms, making regular screening essential for preventing avoidable vision loss. AI-enabled retinal screening could help expand access to early detection in settings where specialist ophthalmology services are limited.
Strategic Impact
The FDA clearance gives iHealthScreen a commercially available AI screening product in the U.S. and establishes a foundation for its broader SaMD strategy. The company is also pursuing additional clearances for the detection of age-related macular degeneration, glaucoma, hypertensive retinopathy, and cardiovascular disease risk.
Source: Businesswire
