Israel-based digital cell morphology imaging provider Scopio Labs has secured the US Food and Drug Administration (FDA) De Novo approval for its full-field bone marrow aspirate (FF-BMA) application.

The digital application is designed to run on the company’s X100 and X100HT platforms, to transform the BMA analysis with a new, fully digital workflow.

The solution combines high-resolution full-field imaging with an AI-powered decision support system (DSS), to benefit healthcare professionals and patients.

It enables hematopathologists to remotely access and review bone marrow smears, reducing turnaround time, and enabling collaboration, expert second opinions, and diagnostic confidence.

Scopio Labs CEO Itai Hayut said: “We commend the FDA for acknowledging the essential need to support haematology experts in their complex work.

“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.”

Bone marrow cytology refers to the microscopic analysis of cells in bone marrow samples, and is a key diagnostic tool used to identify a wide range of blood disorders.

According to the company, haematologic malignancies account for about 10% of all diagnosed cancers in the US and are a major cause of the global cancer burden.

BMA plays a key role in diagnosing cancers, where traditional methods are labour-intensive, time-consuming, and dependent on skilled hematopathologists.

Scopio Labs said its FF-BMA application is designed to help trained operators in reviewing BMA, by automating the detection and visualisation of hematopoietic cells in stained smears.

The solution facilitates essential evaluations such as bone marrow smear quality assessment, blast cell and plasma cell estimation, and calculation of the myeloid to erythroid ratio.

Furthermore, the advanced tool aims to standardise BMA analysis, enhance diagnostic precision, and improve patient care, said the medical imaging solutions provider.

BMA study lead investigator Adam Bagg said: “Scopio’s FF-BMA Application addresses the urgent need for digital innovation amid the rising prevalence of hematologic 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.”