Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

FDA Clearance for Medical Imaging Analytics Cloud Software

January 10, 2017 By PR Newswire

Arterys, a cloud-based medical imaging software, received 510(k) clearance to market its Arterys Cardio DL application.

Arterys Cardio DL is the first technology to be cleared by the FDA that leverages cloud computing and deep learning in a clinical setting. It provides automated, editable ventricle segmentations based on conventional cardiac MRI images that are as accurate as segmentations performed manually by experienced physicians.

The U.S. clearance complements the CE Mark received in late December for commercialization of the Arterys Cardio DL product in Europe.

“Arterys is committed to broadly accelerate the transformation of data-driven medicine through advanced cloud medical imaging analytics applications while always protecting patient data privacy,” said Fabien Beckers, Arterys CEO. “Today’s approval signifies a major regulatory milestone. This application demonstrates the power of deep learning combined with cloud supercomputation to aid physicians in interpreting medical images – eliminating tedious manual tasks carried out on a workstation by accurately automating those processes.”

Unlike traditional medical imaging software, Arterys Cardio DLTM uses deep learning, a form of artificial intelligence, to automate time-consuming analyses and tasks that are performed manually by clinicians today. The physician can edit the automated contours if desired. These images show the Cardio DLTM generated contours of the insides and outsides of the ventricles of the heart. The software can process a scan in just 10 seconds, compared to manual contouring performed by clinicians. (Credit: PR Newswire)

The Arterys Cardio DL application is vendor agnostic and was developed using data from several thousand cardiac cases.

The software produces editable automated contours, providing precise and consistent ventricular function in seconds. The deep learning algorithm was validated as producing results within an expected error range comparable to that of an experienced clinical annotator. This clearance enables Arterys to make use of its unique clinical annotation platform, which collects ground-truth data every time a user views a study on Arterys.com.

In the future, the deep learning model can be optimized as new data is collected from all global users.

Both the FDA clearance and CE Mark expands on the recently 510(k) cleared 4D Flow post-processing software features that provide comprehensive anatomy and blood flow visualization and quantification within and around the heart in a simple manner.

Related Articles Read More >

A photo of Capstan Medical's mitral valve implant, which uses nitinol.
Capstan Medical’s R&D head discusses the heart valve and robotics startup’s tech, engineering challenges and solutions, advice for others in medtech and how to join his team
An illustration of a neurosurgeon using a robotic endoscope to remove a brain tumor.
MDO Nitinol Innovation Special Report
A photo of Highridge Medical CEO Rebecca Whitney.
Highridge Medical is betting on this spine tech
A photo of the miniature Auxilium Biotechnologies implants made on the International Space Station.
Implants 3D-printed in space could enable nerve regeneration
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe