What You Should Know:
– Scopio Labs, a leader in digital cell morphology, has achieved a major breakthrough with FDA De Novo clearance for its Full-Field Bone Marrow Aspirate (FF-BMA) Application.
– The FDA clearance marks a pivotal moment, establishing the first-ever regulatory category for digital bone marrow aspirate analysis software in the US.
Bone Marrow Analysis: Crucial for Diagnosing Blood Disorders
Microscopic analysis of bone marrow samples, known as bone marrow cytology, remains a vital tool for diagnosing a wide range of blood disorders. Hematologic malignancies, a leading cause of global cancer burden, account for roughly 10% of all diagnosed cancers in the US. Bone marrow aspirates (BMAs) play a crucial role in diagnosing these and other blood conditions.
Traditional Challenges and the Digital Solution
However, traditional manual analysis of BMAs is labor-intensive, time-consuming, and relies heavily on highly skilled hematopathologists, impacting efficiency and accessibility. Scopio’s FF-BMA Application revolutionizes this process by introducing a fully digital workflow seamlessly integrated with their X100 and X100HT platforms.
Benefits for Healthcare Professionals and Patients
This innovative solution combines:
- High-resolution Full-Field imaging: Provides a comprehensive view of the sample for detailed analysis.
- AI-powered decision support system (DSS): Assists with tasks like cell detection and categorization, improving efficiency.
“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.”