• 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 » FDA permits marketing of pain relief device for kids with IBS

FDA permits marketing of pain relief device for kids with IBS

June 10, 2019 By Sarah Faulkner

Innovative Health Solutions updated logoThe FDA reported last week that it permitted marketing of the first medical device to reduce functional abdominal pain in patients ages 11-18 with irritable bowel syndrome.

The U.S. regulatory body said the IB-Stim device, made by Innovative Health Solutions, could be used by this patient population when combined with other IBS therapies.

The device features a small, single-use electrical nerve stimulator that is placed behind a user’s ear. The device contains a chip that gives off low-frequency electrical pulses, stimulating branches of certain cranial nerves continuously for five days, according to the FDA.

In reviewing the IB-Stim device, the FDA looked at data from a 50-person clinical study. The study evaluated change from baseline to the end of three weeks in abdominal pain, usual pain and pain frequency severity duration scores.

An analysis showed a greater improvement in the worst pain from baseline to week three in the treatment group compared to the placebo group, according to the FDA. Use of the IB-Stim device also resulted in a 30% decrease in usual pain at the end of three weeks in 52% of treated patients.

Innovative Health Solutions’ product is contraindicated for people with hemophilia, cardiac pacemakers or psoriasis vulgaris, the FDA reported.

“This device offers a safe option for treatment of adolescents experiencing pain from IBS through the use of mild nerve stimulation,” Carlos Peña, director of the Office of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health, said in prepared remarks.

“Today’s action reflects our ongoing commitment to advancing the development of pediatric medical devices so that children and adolescents have access to safe and effective medical devices that meet their needs,” he added.

Filed Under: Featured, Food & Drug Administration (FDA), Pain Management, Regulatory/Compliance Tagged With: innovativehealthsolutions

More recent news

  • Medtronic Diabetes names CFO with consumer experience ahead of separation
  • Preceptis Medical has a new CEO as it advances ear tube tech
  • FDA clears first over-the-counter cuffless blood pressure monitor
  • Mendaera wins FDA clearance for robotic needle placement
  • Johnson & Johnson seeks to have $442 million antitrust verdict tossed out

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