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
    • Educational Assets
    • 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 Approval of GE’s Invenia Automated Breast Ultrasound System

June 3, 2014 By PR Newswire

First U.S. Installs of Next-generation Breast Imaging Technology at Fairfax Radiological Breast Diagnostic Imaging Center in D.C. and Phelps Memorial Hospital in NY

GE Healthcare has announced FDA approval and the U.S. launch of their new breast imaging technology, the Invenia ABUS, proven to help clinicians find 35.7% more cancers in women with dense breasts than mammograms alone1. In keeping with a strong commitment to furthering the fight against breast cancer, GE Healthcare is excited to unveil the first Invenia ABUS installations with Fairfax Radiological Consultants (FRC) just outside of Washington, D.C., and Phelps Memorial Hospital in Westchester, NY, whose healthcare providers are now able to offer women with dense breast tissue an efficient, comfortable and non-ionizing screening solution.

“A growing body of research suggests the importance of screening ultrasound for women with dense breast tissue—that’s about 40% of women,” said breast imaging specialist Elise L. Berman, M.D., of Fairfax Radiological Consultants. “Mammography is still considered the gold standard for breast cancer screening but is less sensitive in women who have dense breast tissue. Supplementing the mammogram with automated breast ultrasound screenings should help us find tumors that cannot be seen on the mammogram and at an earlier stage than would have otherwise been found. We are optimistic that this more personalized screening approach can help us save more women’s lives.”

The Invenia ABUS enhances the patient experience by using 3D ultrasound technology to comfortably and quickly image women with dense breast tissue in approximately 15 minutes with new features that conform to a woman’s body and provide more enhanced images. This launch comes at a critical time when there is growing awareness of the increased risk of cancer for women with high breast density. The more dense breast tissue a woman has, the higher her risk of developing breast cancer2 – oftentimes up to 4-6 times greater risk than women who do not have dense breast tissue3.

“Phelps Memorial Hospital Center prides itself on keeping up with cutting-edge technologies and we are very excited for our hospital and community to integrate this new technology into our mammography program,” noted Senior Administrative Director of Ancillary Services at Phelps Memorial Hospital, Michael Glennon. “This highly sophisticated ABUS is more efficient than the traditional ultrasound exam and will significantly enhance our diagnostic capabilities and potentially improve outcomes for our patients.”

Recognizing that breast cancer screenings can be an emotionally stressful experience for the patient, GE Healthcare has designed the Invenia ABUS with the patented Reverse Curve transducer to conform to a woman’s anatomy, for better comfort and image performance. Further, the system uses Compression Assist, a feature which applies light levels of compression automatically to the breast for increased ease and image reproducibility. Following on the initial Fairfax and Westchester launches, GE plans to roll out the Invenia ABUS nationwide in 2014, with health providers across the country.

“We are excited about launching our most innovative and intuitive ABUS system yet, the Invenia ABUS, and are proud to make our first installs at the renowned facilities at Fairfax Radiological and Phelps Memorial,” said Anders Wold, president and CEO of GE’s ultrasound business. “As part of our ongoing commitment to improving women’s health, GE Healthcare is focused on providing timely and meaningful technological innovations spanning the care continuum, including those for the screening of patients with dense breasts.”

1 FDA PMA P110006 summary of safety and effectiveness.
2 Boyd NF et al. Mammographic Density and the Risk and Detection of Breast Cancer. NEJM 2007; 356: 227-36. Boyd, et al, NEJM Jan 2007.
3 Tabar L, et al. Swedish two county trial: impact of mammographic. 2011;260:658 63.

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
    • Educational Assets
    • 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