Medical Device Network

Scopio Labs’s digital bone marrow aspirate application receives FDA clearance

The FF-BMA Application transforms BMA analysis with a completely digital workflow that integrates with Scopio's X100 and X100HT platforms.

Scopio Labs has obtained the US Food and Drug Administration’s (FDA) De Novo clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) Application.

This clearance fast-tracks the shift to AI-powered digital hematopathology, improving diagnostic speed and patient care.

The FF-BMA Application is designed to transform analysis on BMA with a completely digital workflow that seamlessly integrates with Scopio's X100 and X100HT platforms.

Due to the combination of high-resolution Full-Field imaging with an AI-driven decision support system (DSS), this solution is expected to greatly benefit healthcare professionals and patients.

It allows haematopathologists to gain access and remotely review the bone marrow smears through a secure hospital network, thereby cutting turnaround time, boosting collaboration, facilitating expert second opinions, and enhancing diagnostic confidence.

This FF-BMA Application is tailored to assist operators in the efficient review and reporting of BMA. It automates the detection and visualisation of haematopoietic cells in stained smears.

The application aids in critical evaluations such as assessing the quality of bone marrow smears, estimating the number of blast and plasma cells, and calculating the myeloid to erythroid ratio.

Scopio Labs CEO Itai Hayut said: “The approval of the FF-BMA Application arms them with robust decision support systems. By harnessing AI and Full-Field imaging, labs can streamline workflows, reduce operational costs, and enhance patient care.”

University of Pennsylvania’s Perelman School of Medicine professor of pathology and laboratory medicine and the BMA study's lead investigator Adam Bagg said: “Scopio's FF-BMA Application addresses the urgent need for digital innovation amid the rising prevalence of haematologic conditions and healthcare demands.

“By optimising digital workflows and enabling unique remote review of entire smears, we are hopeful this technology can help enhance efficiency across the board.”

Last year, Siemens Healthineers agreed to serve as the distributor for Scopio Labs’s Scopio X100 and Scopio X100HT imaging platforms across the world.