FDA Clears First-in-World Hematology App, Unlocking Potential of Diagnosis

What You Should Know:

Current Traction.

Blood is one.
of the most foundational entrances to health information. Approximately 120,000.
laboratories around the world conduct 600 million PBS tests every year for the global.
population, primarily through manual microscopes. Even with the adoption of.
digital tools, todays options do not showcase all needed areas of.
interest in a PBS slide, only capturing photos of cells. Subsequently,.
technologists regularly default to the manual microscopic lense for a more in-depth.
examination of the raw information..

Scopio Labs, a leading provider of Full Field Morphology (FFM), revealed that it was.
granted FDA clearance to market and offer its X100 with Full Field Peripheral.
Blood Smear (Full Field PBS) Application, unlocking the potential of in.
vitro hematology diagnosis. Complete Field PBS is also available in Europe with CE mark accreditation approved previously this year..

Complete Field Peripheral Blood Smear (Full Field PBS) Application.

— Scopio Labs announced FDA clearance of its AI-powered
X100 microscope and choice assistance system with Full Field Peripheral Blood
Smear (Full Field PBS) application..

” Understanding the challenges lab hematopathologists, specialists and hematologists face when examining blood samples including big numbers of morphologically-unique cells in a timely fashion, we created our option particularly for hematology labs where we can enhance quality of care, consistency of results and reduce evaluation time,” said Scopio Labs CEO and Co-Founder, Itai Hayut. ” We are delighted to get FDA clearance following the effective completion of a multi-center research study, as we bring our innovative solution to labs around the U.S. to assist improve the result of diagnosis and care.”.

— Using sophisticated computational photography imaging and customized AI tools, Full Field PBS offers clinical labs an extraordinary ability to capture digital scans with full-field view of the monolayer and feathered edge at 100X oil immersion resolution level..

< -- The worldwide market for hematology analyzers and reagents. is presently $7.6 billion and is anticipated to reach $10.6 billion by 2025. Why It. Matters. Earlier this. year, the business closed a $ 16 million Series B funding round, bringing overall funding to $30 million. Scopio Labs is setting its sights. on changing all hematology applications, including bone marrow aspirates. ( BMA) and body fluids. With a robust item advancement pipeline, and the. capability to find morphological events on a cellular and subcellular scale,. Scopio Labs will open the door for morphology-based diagnostics, disease. tracking and treatment change for various blood cancers.. To assist enhance diagnostic accuracy leveraging unique computer system vision tools, Full Field PBS provides scientific laboratories an unprecedented ability to record digital scans utilizing advanced computational photography imaging and tailored AI tools. The Full Field PBS uses adaptive monolayer recognition in assistance of short and long smears and automates the analysis process by pre-classifying 200 white blood cells (WBC), supplying platelet pre-estimate, and enabling RBC morphology assessment. Accelerating routine analysis, Full Field PBS consists of a customized decision assistance system for pre-classification of leukocyte into 16 classes, red cell morphology examinations, platelet location and count.