Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

FDA Approves ‘Artificial Pancreas’ to Manage Diabetes

September 29, 2016 By Matthew Perrone, AP Health Writer

Federal regulators have approved a first-of-a-kind “artificial pancreas,” a device that can help some diabetes patients manage their disease by constantly monitoring their blood sugar and delivering insulin as needed.

The device from Medtronic was approved Wednesday for patients with Type 1 diabetes, the kind usually diagnosed during childhood. About 5 percent of the nation’s 29 million Americans with diabetes have this type.

Doctors said they have long awaited a device that could help patients around the clock.

“I can’t wait to get my hands on it because I can think of a lot of our patients who need this,” said the Cleveland Clinic’s Dr. Betul Hatipoglu. “Now I have a helper who is going to help me to help them.”

Type 1 diabetes patients now have to manage their insulin through multiple injections throughout the day or a drug pump that delivers it through a tube. Their own pancreas doesn’t make insulin, a hormone needed to turn food into energy. They face increased risks of dangerously high blood-sugar levels, heart disease and many other health problems.

The new MiniMed 670G consists of a drug pump, a sensor that measures blood sugar and a tube that delivers the insulin. The sensor measures sugar levels every 5 minutes, infusing or withholding insulin as needed. Patients still have to manually increase insulin before meals.

This image provided by Medtronic shows its MiniMed 670G system. Federal regulators have approved a first-of-a-kind “artificial pancreas,” a device that can help some diabetes patients manage their disease by constantly monitoring their blood sugar and delivering insulin as needed. The device from Medtronic was approved Wednesday, Sept. 28, 2016, for patients with Type 1 diabetes, the kind usually diagnosed during childhood. (Credit: Medtronic via AP)

Medtronic said the device will cost between $6,000 and $9,000, similar to its other insulin pumps.

Older insulin pumps simply deliver a baseline level of insulin, and patients must monitor their sugar levels and give themselves more insulin to keep their blood sugar from getting too high. A big danger is having too much insulin in the body overnight, when blood-sugar levels naturally fall. People can go into comas, suffer seizures and even die.

The Food and Drug Administration said it approved the device based on a three-month study of more than 120 patients. The study reported no major adverse events, such as dangerously low blood sugar, showing that the device is safe for those 14 years and up, regulators said in a release.

The pump is about the size of a deck of cards and can be worn on a belt or carried in a pocket.

The device “can provide people with Type 1 diabetes greater freedom to live their lives,” said Dr. Jeffrey Shuren, director of the FDA’s device center.

While the device can currently only be marketed for Type 1, doctors said it could eventually be used by those with Type 2 diabetes, where the body gradually loses the ability to produce or use insulin. Many of those patients are overweight or obese and face increased risk of heart attack, stroke and kidney failure.

“Type 2 diabetes is such an overwhelming spectrum of the disease and I think there’s a significant slice of that pie that could benefit from the artificial pancreas,” said Dr. Robert Courgi of Southside Hospital on New York’s Long Island.

The agency said it is requiring Ireland-based device manufacturer Medtronic to further study the implant’s performance in patients. The company is also studying the device for potential use in children ages 7 to 13.

A number of other companies are developing similar products, including Dexcom and Johnson & Johnson.

Related Articles Read More >

An illustration of the Endogenex ReCET system inside a patient.
This minimally invasive diabetes device delivers pulsed field energy in the gut
UCSD diabetic kidney disease.
New imaging technology offers noninvasive 3D view of diabetic kidney disease
May 2025 edition: Inhalable vaccine delivery, type 2 diabetes tech and Medtronic aDBS
A portrait of former Insulet Chief Technology Officer Mark Field.
Ex-Insulet CTO Mark Field has a new job in medtech with ITJ
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

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.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. 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 LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Educational Assets
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe