FDA Greenlights Scopio Labs' Trailblazing Digital Solution for Bone Marrow Analysis

Thursday, April 18, 2024

Scopio Labs, known for its pioneering Full-Field Digital Cell Morphology™ imaging and analysis platforms, has received De Novo clearance from the U.S. Food and Drug Administration (FDA) for its innovative Full-Field Bone Marrow Aspirate™ (FF-BMA) Application. This clearance marks a significant advancement, creating a new regulatory category for digital bone marrow aspirate analysis software.

Bone marrow cytology is a crucial diagnostic tool for a wide range of blood disorders, including hematologic malignancies, which account for about 10 percent of all diagnosed cancers in the U.S. Traditional manual analysis methods are labor-intensive and time-consuming, relying heavily on skilled hematopathologists for accuracy.

Scopio's FF-BMA Application transforms bone marrow aspirate analysis by introducing a fully digital workflow integrated with the X100 and X100HT platforms. Combining high-resolution Full-Field imaging with an AI-powered decision support system (DSS), this solution aims to empower healthcare professionals and improve patient care by enabling remote access and review of bone marrow smears. This facilitates collaboration, reduces turnaround time, and enhances diagnostic confidence.

The FF-BMA Application automates hematopoietic cell detection and visualization in stained smears, streamlining review and reporting processes. It assists in essential evaluations such as smear quality assessment, blast cell and plasma cell estimation, and myeloid to erythroid (M:E) ratio calculation, standardizing BMA analysis and improving diagnostic precision.

Source: prnewswire.com