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Scopio Labs Gets FDA Clearance for Digital Bone Marrow Aspirate Application

NEW YORK — Scopio Labs said Wednesday that it has received de novo clearance from the US Food and Drug Administration for a digital bone marrow aspirate application that runs on its digital morphology systems.

The FF-BMA Application automates the detection and visualization of hematopoietic cells in stained smears to help in clinical evaluations such as bone marrow smear quality assessment, blast cell and plasma cell estimation, and myeloid-to-erythroid ratio calculation, according to Tel Aviv, Israel-based Scopio.

The application runs on the Israeli company's FDA-cleared X100 system, which uses digital imaging and AI to automate peripheral blood smear analysis. It can also run on Scopio's high-throughput X100HT system, which was cleared by the FDA in mid-2022 and can process up to 40 samples per hour.