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FDA clears Scopio digital bone marrow aspirate application

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April 25, 2024—Scopio Labs announced it has been granted de novo clearance by the FDA for its Full-Field Bone Marrow Aspirate application for use on the company’s X100 and X100HT platforms. The application is designed to assist users in streamlining bone marrow aspirate review and reporting. It automates the detection and visualization of hematopoietic cells in stained smears, facilitating evaluations such as bone marrow smear quality assessment, blast cell and plasma cell estimation, and calculation of the myeloid to erythroid ratio.

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