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RETINA-AI Health has developed the Galaxy™ platform, an FDA-regulated Software as a Medical Device that uses deep learning to autonomously detect moderate or worse diabetic retinopathy from retinal images taken in primary care settings. The system provides rapid results and actionable reports to facilitate early detection and referral. As of late 2022, the company began enrollment in a pivotal Phase III multi-center prospective clinical trial for its v2.0 system with multi-camera compatibility. The product has been deployed commercially for diabetic retinopathy screening; additional indications are under development.
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