• 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 » Insulet resumes next-gen Omnipod pivotal study following software issues

Insulet resumes next-gen Omnipod pivotal study following software issues

June 5, 2020 By Danielle Kirsh

insuletInsulet (NSDQ:PODD) today said it has resumed its pivotal study of its next-generation Omnipod Insulin Management System after pausing the study in March due to a software anomaly.

The company paused the study about halfway through completion to correct an issue that could result in the system using an incorrect glucose value that had the potential to impact insulin delivery, according to the company. No adverse events it had been reported due to the software issue.

“We are thrilled to continue our trial,” senior VP and medical director Trang Ly said in a news release. “We have encouraging data from our clinical work to date and overwhelmingly positive feedback from participants and investigators. We are excited about what our next-generation Omnipod, Powered by Horizon, will offer people living with diabetes.”

The U.S. Dept. of Homeland Security also issued a medical advisory to warn of vulnerabilities of the Omnipod insulin management system in March. Because of the vulnerability, and attacker with access to one of the affected pump models was able to intercept or modify data while also being able to change pump settings and control insulin delivery.

Insulet expects to commercialize the next-generation Omnipod in the U.S. during the first half of 2021, pending FDA clearance.

Filed Under: Diabetes, Drug-Device Combinations, Featured Tagged With: Insulet

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

About Danielle Kirsh

Danielle Kirsh is an award-winning journalist and senior editor for Medical Design & Outsourcing, MassDevice, and Medical Tubing + Extrusion, and the founder of Women in Medtech and lead editor for Big 100. She received her bachelor's degree in broadcast journalism and mass communication from Norfolk State University and is pursuing her master's in global strategic communications at the University of Florida. You can connect with her on Twitter and LinkedIn, or email her at [email protected].

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