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Scopio Labs Receives Groundbreaking FDA Clearance for First-Ever Digital Bone Marrow Aspirate Application

The company's 3rd FDA clearance accelerates the shift to AI-powered digital hematopathology, enhancing diagnostic speed and patient care

TEL AVIV, Israel , April 17, 2024 /PRNewswire/ — 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.

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.

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