FDA Clears AI-Powered Blood Smear for Hematology Diagnostics

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The Full Field Peripheral Blood Smear application addresses shortcomings of current digital solutions.

The US Food and Drug Administration (FDA) has approved the Full Field Peripheral Blood Smear (Full Field PBS) Application for use in in vitro hematology diagnosis.

Full Field PBD was developed by Scopio Labs and uses advanced computation photography imaging and tailored AI tools. This allows clinical laboratories the ability to capture digital scans with full field view of the the monolayer and feathered edge at 100X oil immersion resolution level.

Furthermore, the technology utilizes monolayer identification in support of long and short smears and automates the analysis process by pre-classifying 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," said Scopio Labs' CEO and Co-Founder, Itai Hayut in a statement.

"We are thrilled to receive FDA clearance following the successful completion of a multi-center study, as we bring our innovative solution to laboratories around the U.S. to help improve the outcome of diagnosis and care." 

Globally, about 120,000 laboratories conduct 600 million PBS tests, with an overreliance on manual microscopes. Even though clinics have generally adopted digital tools, these technologies fall short in capturing regions of interest in a PBS slide.

However, to combat these shortcomings, Full Field PBS offers a fully digital, automated scan and image acquisition system, and provides users with a modern web browser interface that supports in-slide navigation to specified locations within a slide.

Earlier this year, Full Field PBS received CE mark certification in Europe.