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

  • COVID-19
  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • Artificial Intelligence
    • Blockchain
    • Mobile Health
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage
  • Life Sciences
  • Research

Arterys Receives FDA 510(k) Clearance for 4D Blood Flow Image Analysis

by Fred Pennic 11/04/2016 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

arterys-receives-fda-510k-clearance-for-4d-blood-flow-image-analysis

Arterys, a provider of cloud-based medical imaging software has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Arterys Software. The FDA clearance will allow Arterys’ proprietary cloud platform to be used in clinical settings for the quantification of cardiac flow to collect and process very large data sets in real-time, resulting in fast, comprehensive cardiac exams.

 

The product seamlessly integrates into clinical practice to provide comprehensive, simple and quick Cardiac MR imaging. Previously, the Arterys Software received FDA clearance for its 4D Flow visualization feature.

The product specifically analyzes the blood flow to the heart and its major vessels using multi-slice, multi-phase and velocity encoded MR images in 4D. It provides clinically-relevant and reproducible, quantitative data, and it has been tested and validated on MR images acquired from both 1.5T and 3.0T MR Scanners.

The data produced by the Arterys Software is intended to be used to support qualified cardiologists, radiologists, and other licensed healthcare practitioners for clinical decision-making. The main clinical applications of the Arterys Software include complex congenital heart disease, shunts and collateral vessels, aortic disease and valvular disease.

“Since our founding just five years ago, Arterys has been committed to transforming clinical practice through powerful, quantitative imaging analytics that rapidly capture and analyze unprecedented amounts of data for use in guiding treatment decisions and patient care,” said CTO John Axerio-Cilies in a statement.

Understanding 4D Flow

The cardiac 4D Flow technique refers to phase-contrast Cardiac Magnetic Resonance (CMR) velocity-encoded in all three spatial directions, and resolved relative to all three dimensions of space and time along the cardiac cycle (3D + time). This advanced technology allows physicians to measure and visualize blood patterns within the acquired 3D volume. Unlike conventional MRI, where multiple scans are taken while the patient holds their breath, the 4D Flow sequence is provides faster scans and simplified processes.

Following FDA clearance, Arterys plans on launching the product in the US through a partnership with GE Healthcare as the ViosWorks 4D product. The company is also actively pursuing additional regulatory approval in other global markets.

 

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: Arterys, FDA clearance 510k, FDA Cleared Devices

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

Knowledge Hub

How AI Helps Health Systems Improve the Quality of Care for Patients with Chronic Conditions

How AI Helps Health Systems Improve the Quality of Care for Patients with Chronic Conditions

10 Critical KPIs Every Successful Healthcare Organization is Implementing10 Critical KPIs Every Successful Healthcare Organization is Implementing

Trending

Why The Evolution of Tech Will be Based on APIs

Why The Evolution of Tech Will be Based on APIs

Podimetrics CMO Talks Supporting Patients Living with SDoH Challenges

Podimetrics Director Talks Supporting Patients Living with SDoH Challenges

: Does Alzheimer’s Cure Matter if We Don't Fix the Economic Infrastructure of the Disease?

Does Alzheimer’s Cure Matter if We Don’t Fix the Economic Infrastructure of the Disease?

Recent Digital Health Partnerships

Roundups: 15 Recent Digital Health Strategic Partnerships

Recent Digital Health Executive Hires & Board Appointments

Digital Health Executive Hires: Practice Better Appoints CEO, HHAeXchange, Intelerad, Tegria, Others

M&A: Florence Acquires Virtual Care Solution Zipnosis

M&A: Florence Acquires Virtual Care Solution Zipnosis

Adopting Value-Based Care Models for Autism Care Is Imperative

Why Adopting Value-Based Care Models for Autism Care Is Imperative

UNC Health to Pilot Epic, Microsoft’s Generative AI Tool

UNC Health to Pilot Epic, Microsoft’s Generative AI Tool

Vanderbilt University Medical Center Taps Philips Reduce Carbon Footprint

Vanderbilt University Medical Center Taps Philips to Reduce Carbon Footprint

Denials Management Named Most Time-Consuming Task in RCM

Denials Management Named Most Time-Consuming Task in RCM

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • 2023 Editorial Calendar
  • 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 © 2023. HIT Consultant Media. All Rights Reserved. Privacy Policy |