FDA grants clearance for first-ever digital bone marrow aspirate application – Scopio Labs

Scopio Labs, developer of Full-Field Digital Cell Morphology imaging and analysis platforms and a recognized leader in digital morphology, announced that it has been granted De Novo clearance by the 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.

Bone marrow cytology, the microscopic analysis of cells in bone marrow samples, remains a crucial diagnostic tool for a wide range of blood disorders. Hematologic malignancies account for about 10 percent of all diagnosed cancers in the U.S. and remain a leading cause of the global cancer burden. Bone marrow aspirate (BMA) plays a vital role in diagnosing these and other hematologic conditions, both malignant and benign. However, traditional manual methods are labor-intensive, time-consuming, and heavily reliant on highly skilled hematopathologists to ensure accuracy.

Scopio’s FF-BMA Application addresses the urgent need for digital innovation amid the rising prevalence of hematologic conditions and healthcare demands,” said Adam Bagg, MD, a Professor of Pathology and Laboratory Medicine in the Perelman School of Medicine at the University of Pennsylvania and a lead investigator in the BMA study that was submitted to the FDA. “By optimizing digital workflows and enabling unique remote review of entire smears, we are hopeful this technology can help enhance efficiency across the board.”.