Scopio Labs has received the US Food and Drug Administration (FDA) approval for its X100 product with Full Field Peripheral Blood Smear (Full Field PBS) application, for in vitro hematology diagnosis.
Full Field PBS is an end-to-end 100X oil immersion resolution digital microscopy solution for PBS, which comprises a three-slide tray and a decision support system (DSS).
With advanced computational photography imaging and tailored AI tools, the solution enables clinical laboratories to capture digital scans with full field view of the monolayer and feathered edge at 100X oil immersion resolution level.
Earlier this year, the Israeli diagnostic technology firm has secured the CE mark approval for Full Field PBS, and is commercialising it in the Europe.
Scopio Labs CEO and co-founder Itai Hayut said: “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.
“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.”
Full Field PBS facilitates pre-classification of WBC and evaluation of RBC morphology
Full Field PBS is said to facilitate pre-classification of WBC into 16 classes, red blood cell (RBC) morphology evaluations, platelet location and pre-estimate.
The advanced microscope features adaptive monolayer identification for optimal imaging and analysis of short and long smears, including the feathered edge of the sample.
Full Field PBS has a fully digital, automated scan and image acquisition system, which is said to provide distinctive user experience of in-slide navigation to specified locations within a slide.
Scopio Labs is focused on transform all hematology applications, including bone marrow aspirates (BMA) and body fluids.
The company closed a $16m Series B funding round earlier this year, taking its total capital raise to $30m.
Scopio Labs co-founder and CTO Erez Na’aman said: “With the first clinical-level solution that digitizes large portions of PBS, Scopio Labs is taking hematology through the next technological revolution with exponential impact to the industry, leveraging its unique computational imaging technology and specifically designed computer vision tools.”
