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Scopio Labs Receives FDA 510(k) Clearance for Automated Hematology Platform

NEW YORK — Israeli hematology firm Scopio Labs said Wednesday that it has received US Food and Drug Administration 510(k) clearance for its X100 hematology imaging and analysis system and its Full Field Peripheral Blood Smear application.

According to Tel Aviv-based Scopio, the product uses digital imaging and AI to automate peripheral blood smear analysis, preclassifying 200 white blood cells, providing platelet pre-estimate, and enabling RBC morphology evaluation.

"Understanding the challenges lab technicians, hematologists and hematopathologists face when evaluating blood samples containing large numbers of morphologically unique cells in a timely fashion, we designed our solution specifically for hematology labs where we can improve quality of care, consistency of results and reduce review time," Itai Hayut, Scopio Labs' CEO and cofounder, said in a statement.

"The field of microscopy is poised for transformation, and I am enthusiastic about the prospects of Scopio Labs' innovative application," said Michael D. Feldman, vice chairman clinical services, pathology and laboratory medicine at University of Pennsylvania School of Medicine. "With new digital technologies combining imaging and artificial intelligence being introduced into the laboratory, we can provide clinicians with tools that strengthen their capabilities."

The product is also available in Europe, having received CE mark certification earlier this year.