Scopio Labs, developer of Full-Field Digital Cell Morphology™ imaging and analysis platforms and a recognized leader in digital morphology, today announced that it has been granted De Novo clearance by the U.S. Food and Drug Administration (FDA) for its Full-Field Bone Marrow Aspirate™ (FF-BMA) Application. This marks a pivotal moment, establishing a new regulatory category for all-digital bone marrow aspirate analysis software.
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