• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage
  • Life Sciences
  • Research

FDA Clears First-Ever Digital Bone Marrow Aspirate App

by Fred Pennic 04/19/2024 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print
FDA Clears First-Ever Digital Bone Marrow Aspirate App

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.”

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: FDA Clearance

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Insights

2025 EMR Software Pricing Guide

2025 EMR Software Pricing Guide

Featured Interview

Paradigm Shift in Diabetes Care with Studio Clinics: Q&A with Reach7 Founder Chun Yong

Most-Read

Medtronic to Separate Diabetes Business into New Standalone Company

Medtronic to Separate Diabetes Business into New Standalone Company

White House, IBM Partner to Fight COVID-19 Using Supercomputers

HHS Sets Pricing Targets for Trump’s EO on Most-Favored-Nation Drug Pricing

23andMe to Mine Genetic Data for Drug Discovery

Regeneron to Acquire Key 23andMe Assets for $256M, Pledges Continuity of Consumer Genome Services

CureIS Healthcare Sues Epic: Alleges Anti-Competitive Practices & Trade Secret Theft

The Evolving Role of Physician Advisors: Bridging the Gap Between Clinicians and Administrators

The Evolving Physician Advisor: From UM to Value-Based Care & AI

UnitedHealth Group Names Stephen Hemsley CEO as Andrew Witty Steps Down

UnitedHealth CEO Andrew Witty Steps Down, Stephen Hemsley Returns as CEO

Omada Health Files for IPO

Omada Health Files for IPO

Blue Cross Blue Shield of Massachusetts Launches "CloseKnit" Virtual-First Primary Care Option

Blue Cross Blue Shield of Massachusetts Launches “CloseKnit” Virtual-First Primary Care Option

Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density

Osteoboost Launches First FDA-Cleared Prescription Wearable Nationwide to Combat Low Bone Density

2019 MedTech Breakthrough Award Category Winners Announced

MedTech Breakthrough Announces 2025 MedTech Breakthrough Award Winners

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |