• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer
  • Advertise
  • Subscribe

MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

  • Latest News
  • Technologies
    • Artificial Intelligence (AI)
    • Cardiovascular
    • Orthopedics
    • Neurological
    • Diabetes
    • Surgical Robotics
  • Business & Finance
    • Wall Street Beat
    • Earnings Reports
    • Funding Roundup
    • Mergers & Acquisitions
    • Initial Public Offering (IPO)
    • Legal News
    • Personnel Moves
    • Medtech 100 Stock Index
  • Regulatory & Compliance
    • Food & Drug Administration (FDA)
    • Recalls
    • 510(k)
    • Pre-Market Approval (PMA)
    • MDSAP
    • Clinical Trials
  • Special Content
    • Special Reports
    • In-Depth Coverage
    • DeviceTalks
  • Podcasts
    • MassDevice Fast Five
    • DeviceTalks Weekly
    • OEM Talks
      • AbbottTalks
      • Boston ScientificTalks
      • DeviceTalks AI
      • IntuitiveTalks
      • MedtechWOMEN Talks
      • MedtronicTalks
      • Neuro Innovation Talks
      • Ortho Innovation Talks
      • Structural Heart Talks
      • StrykerTalks
  • Resources
    • About MassDevice
    • DeviceTalks
    • Newsletter Signup
    • Leadership in Medtech
    • Manufacturers & Suppliers Search
    • MedTech100 Index
    • Videos
    • Webinars
    • Whitepapers
    • Voices
Home » Boston Scientific wins FDA nod for MR-conditional ImageReady pacemaker line

Boston Scientific wins FDA nod for MR-conditional ImageReady pacemaker line

April 26, 2016 By Brad Perriello

Boston ScientificBoston Scientific (NYSE:BSX) said yesterday that it won FDA approval for its ImageReady line of MR-conditional pacemakers, including the Accolade MRI and Essentio MRI pacers and the Ingevity MRI leads.

Marlborough, Mass.-based Boston Scientific, which won CE Mark approval in the European Union for the Ingevity leads in March 2014, said the approval covers for full-body, 1.5 Tesla MRI scans for patients implanted with the full ImageReady system, including active and passive fixation models.

“With a pacing system specifically designed with automatic remote monitoring that also allows patients to undergo MR scans, we are further advancing the quality of patient care,” rhythm management chief medical officer Dr. Kenneth Stein said in prepared remarks. “We believe that the daily monitoring capability of the ImageReady system, coupled with advanced diagnostics, will help physicians identify concerns and ultimately initiate patient care sooner.”

“As shown in the Samurai trial, the ImageReady system gives physicians reassurance that they are implanting pacemakers that are safe in an MRI environment should their patients need scans in the future,” added principal investigator Dr. Ronald Berger of Baltimore’s Johns Hopkins Medical Institutions. “The study demonstrated the Ingevity MRI leads had no MR-related complications and very low rates of complications overall.”

Boston Scientific said it’s also pursuing MRI compatibility for the implantable cardiac defibrillators and cardiac resynchronization therapy devices it already has on the market, with the Enable MRI study it launched earlier this year.

Filed Under: Cardiovascular, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Boston Scientific, Cardiac Rhythm Management

More recent news

  • Comphya raises CHF 7.5 million for neurostim to treat ED
  • Fujifilm launches intelligent automation features for digital radiography
  • Integer appoints former iRhythm CEO to board
  • MMI debuts robotic surgery instruments, digital surgery platform
  • Synchrony Medical wins FDA nod for airway clearance system

Primary Sidebar

“md
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest med device regulatory, business and technology news.

DeviceTalks Weekly

See More >

MEDTECH 100 Stock 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.
MDO ad

Footer

MASSDEVICE MEDICAL NETWORK

DeviceTalks
Drug Delivery Business News
Medical Design & Outsourcing
Medical Tubing + Extrusion
Drug Discovery & Development
Pharmaceutical Processing World
MedTech 100 Index
R&D World
Medical Design Sourcing

DeviceTalks Webinars, Podcasts, & Discussions

Attend our Monthly Webinars
Listen to our Weekly Podcasts
Join our DeviceTalks Tuesdays Discussion

MASSDEVICE

Subscribe to MassDevice E-Newsletter
Advertise with us
About
Contact us

Copyright © 2025 · WTWH Media LLC and its licensors. 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.

Privacy Policy