Scopio Labs receives FDA nod for digital BMAA

Scopio Labs 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.
MB Bureau