An FDA-cleared AI-powered digital microscopy platform that autonomously analyzes peripheral blood smears for automated hematology diagnostics.
AI100 with Shonit is SigTuple's flagship AI-enabled in-vitro diagnostic system that digitizes and analyzes peripheral blood smear specimens using an ensemble of deep learning models. The platform combines a robotic XYZ stage, 14MP CMOS camera, and automated oil immersion with cloud-based AI to localize and classify cells across more than 30 types, delivering 200-cell leukocyte differentials, RBC morphology assessment, and platelet morphology evaluation. The system achieved specificity above 98% and sensitivity above 91% for common cell type identification in clinical studies. It holds U.S. FDA 510(k) clearance and CE certification.
Automated white blood cell differential counts
Red blood cell morphology screening for anemia and other conditions
Platelet aggregate detection
Remote pathologist review of digitized blood smear slides
Reduction in sample review time from 5-10 minutes to approximately 30 seconds
Improved diagnostic accuracy and consistency through standardized AI analysis
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