• 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 » Obalon wins FDA nod for Obalon Nav system

Obalon wins FDA nod for Obalon Nav system

December 21, 2018 By Fink Densford

Obalon Therapeutics

Obalon Therapeutics (NSDQ:OBLN) said today that it won FDA clearance for its Obalon Navigation system intended for use in placing the company’s Obalon Balloon system.

The newly cleared Obalon Navigation system uses magnetic resonance imaging during placement and displays a real-time image of the balloon, the San Diego-based company said. The system is intended for use alongside the automated Touch Inflation Dispenser to improve placement procedures.

“We participated in the clinical trial for the Obalon Navigation system with the Touch Inflation Dispenser and were very impressed with the new technology to make placement of the Obalon Balloon more reliable, safer and easier. We especially appreciated the Obalon Navigation System’s dynamic 3D display during balloon placement, as opposed to the static 2D x-ray images we currently use.  The automated Touch Inflation Dispenser eliminates many of the connections and valves from prior dispenser, which should reduce the potential for error during balloon placement and inflation,” Dr. Mickey Seger of San Antonio’s Texas Bariatric Medical Institute said in a prepared statement.

Obalon said it expects to launch the newly cleared systems during the first quarter of next year.

“We’re very pleased about the approval of the Obalon Navigation system which is intended to make placement of the Obalon Balloon more reliable, more convenient and more accessible to physician providers and patients by eliminating the costs and logistics related to acquiring x-ray. I’d like to recognize the FDA for their timely review of the Obalon Navigation system, as well as the Touch Inflation Dispenser which was previously approved in the third quarter of 2018.  We believe Navigation and Touch provide another step forward in helping physicians and patients battle the obesity epidemic,” prez & CEO Kelly Huang said in a press release.

In September, Obalon said that it won approval from the FDA for a premarket approval supplement application for its Obalon Touch inflation system.

Filed Under: Food & Drug Administration (FDA), Regulatory/Compliance, Weight loss Tagged With: Obalon Therapeutics

More recent news

  • Medtronic escapes $106.5M payment in Colibri TAVR patent suit after court overturns jury verdict
  • RadNet closes iCAD acquisition, expands AI breast‑imaging portfolio
  • Hyperfine reports first commercial sales of next-gen AI-powered Swoop
  • Stereotaxis announces $12.5M offering
  • Nuwellis ends clinical trial of its ultrafiltration tech for heart failure

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