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

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

Medtronic CEO confirms FDA warning could affect approval timing for next-gen diabetes tech

January 10, 2022 By Sean Whooley

Medtronic MiniMed 780G
The Medtronic MiniMed 780G system. [Image from Medtronic]
An FDA warning over Medtronic’s (NYSE:MDT) diabetes business introduces uncertainty into new approvals, the company’s CEO said.

Last month, Medtronic received an FDA warning letter highlighting inadequacies in specific medical device quality system requirements at its diabetes business’ Northridge, California, facility. Today at the 40th Annual J.P. Morgan Healthcare Conference, CEO Geoff Martha said there is now some uncertainty over the timing of approval for next-generation platforms, including the MiniMed 780G insulin pump and Guardian 4 continuous glucose monitoring (CGM) sensor.

“Our extensive remediation efforts are well underway,” Martha said. “We’re working to resolve the warning letter as quickly as possible.”

Martha said Medtronic has confidence in its diabetes business, despite being unable to share much information on its mid-to-long-term pipeline because of competitive reasons. However, he said the company is currently advancing multiple programs, including what he labeled competitive CGM and patch-pump technology.

“We’re confident that we can bring value to patients and create value for shareholders,” Martha said.

Launches are expected in the coming quarters for the MiniMed 780G pump and Guardian 4 sensor. Medtronic’s portfolio also includes the Simplera disposable CGM sensor (formerly Synergy), among other undisclosed development programs.

Martha confirmed that the company’s investment in medtech over the mid-to-long term includes multiple diabetes programs surrounding next-generation insulin pumps and CGM/patch-pump technologies.

“We’re focused on the long term and intend to maintain important investments to deliver on this,” Martha said.

Filed Under: Auto-injectors, Business/Financial News, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Patient Monitoring, Regulatory/Compliance, Research & Development Tagged With: Medtronic

IN CASE YOU MISSED IT

  • Abbott could pave new roads in diabetes management with dual sensor on the horizon
  • Tandem Diabetes Care pairs t:slim X2 pump with Abbott FreeStyle Libre 3 Plus in U.S.
  • Ypsomed, CamDiab to integrate Abbott dual glucose-ketone sensor into automated insulin delivery system
  • PharmaSens, SiBionics collab on all-in-one insulin patch pump
  • Beta Bionics to pair iLet automated insulin delivery system with Abbott’s dual glucose-ketone sensor

About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

Primary Sidebar

“ddb
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news and trends happening now in drug delivery.

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.

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing + Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts

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 | RSS