TEL AVIV, Israel, – April 17, 2024 – 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.

Scopio’s FF-BMA Application transforms BMA analysis by introducing a fully digital workflow that seamlessly integrates with Scopio’s X100 and X100HT platforms. By combining high-resolution Full-Field imaging with a robust AI-powered decision support system (DSS), this solution aims to significantly benefit healthcare professionals and patients. It enables hematopathologists to access and review bone marrow smears remotely (via a secure hospital network), reducing turnaround time, fostering collaboration, facilitating expert second opinions, and bolstering diagnostic confidence.

“We commend the FDA for acknowledging the essential need to support hematology experts in their complex work,” said Itai Hayut, CEO of Scopio Labs. “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.”

“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.”

The FF-BMA Application is designed to assist trained operators in streamlining BMA review and reporting. It automates the detection and visualization of hematopoietic cells in stained smears, thus facilitating essential evaluations such as bone marrow smear quality assessment, blast cell and plasma cell estimation, and calculation of the myeloid to erythroid (M:E) ratio. This innovative tool aims to standardize BMA analysis, elevate diagnostic precision, and ultimately improve patient care.

For a comprehensive overview of Scopio Labs’ Full-Field Digital Cell Morphology™ solutions, including the FF-BMA Application, please contact us.

About Scopio Labs

Scopio Labs is the developer of full-field digital imaging for hematology diagnostics. By supporting laboratory scientists and clinicians with unprecedented scale and depth in digital cell morphology, the company’s platforms enable timely detection of blood-related medical conditions, expediting patients’ access to life-saving treatments.

Scopio solves cell morphology’s age-old trade-off between resolution and field of view. Its high-resolution imaging and embedded AI combine for more efficient remote workflow, contributing to better diagnostics across the continuum of care.

Scopio Labs’ Full-Field Peripheral Blood Smear Application and Full-Field Bone Marrow Aspirate Application are FDA-cleared and CE-marked for use with the Scopio X100 and Scopio X100HT platforms. To learn more, visit www.scopiolabs.com.

Media contact

Lianne Trantz
lianne.trantz@scopiolabs.com
+972 50-272-7929