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

Scopio Labs, a leading provider of Full Field Morphology (FFM), announced that it was granted FDA clearance to market and sell its X100 with Full Field Peripheral Blood Smear (Full Field PBS) Application, unlocking the potential of in vitro hematology diagnosis. Full Field PBS is also available in Europe with CE mark certification granted earlier this year. Blood is one of the most foundational gateways to health information. Even with the adoption of digital tools, today's solutions do not showcase all required regions of interest in a PBS slide, only capturing snapshots of cells. To help improve diagnostic accuracy leveraging novel computer vision tools, Full Field PBS gives clinical laboratories an unprecedented ability to capture digital scans using advanced computational photography imaging and tailored AI tools.