This important clearance builds on Scopio Labs’ proven track record of innovation, enhancing its already FDA-cleared Full-Field Peripheral Blood Smear (PBS) Application. The upgraded solution is designed to empower qualified hematology lab professionals and enhance their conventional analysis methods by examining thousands of cells and providing intelligent, AI-driven analysis and grading for 23 distinct RBC morphology parameters and for the presence of platelet clumps, across the clinically relevant areas of the sample, from the monolayer to the feathered edge. This leap forward supports greater consistency and efficiency in analysis, while crucially maintaining the essential oversight of human experts in the diagnostic process.

“These enhancements bring added consistency and efficiency to digital morphology review,” said Itai Hayut, CEO at Scopio Labs. “With this FDA clearance, we’re proud to extend access to our decision support capabilities to US-based hematology labs, supporting clinical teams with solutions that align seamlessly with established workflows”