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The Eye as a Biomarker: Why Retinal AI Could Reshape How Trials Screen and Stratify ...
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Fusion42 · 10 October 2026 · Fusion42 review
Visionary AI, a deep-learning platform analysing retinal images, offers a non-invasive biomarker for predicting hypertensive disorders in pregnancy, potentially transforming patient stratification in clinical trials. Regulatory guidance for AI in medical devices is evolving but remains unclear for clinical trial use, posing validation and compliance challenges for sponsors adopting retinal AI for trial enrichment.
This Wire brief sits within Fusion42's coverage of Digital Health.
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You face a regulatory grey zone using retinal AI for patient screening in trials that demands prospective validation tailored to your cohort. Early compliance focus will open trial access before competitors scale their models across populations.
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1 source · 8 Oct 2026
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