• 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 » Tandem Diabetes Care wins FDA clearance for Basal-IQ tech as interoperable automated glycemic controller

Tandem Diabetes Care wins FDA clearance for Basal-IQ tech as interoperable automated glycemic controller

March 2, 2020 By Danielle Kirsh

Tandem Diabetes Care - updatedTandem Diabetes Care (NSDQ:TNDM) this week announced that it won FDA clearance for its Basal-IQ technology for interoperable automated glycemic control (iAGC).

The FDA has only classified three categories for the interoperability of devices as a complete automated insulin dosing (AID) system, an integrated continuous glucose monitoring and an iAGC.

“Aligning Basal-IQ technology with Control-IQ technology under the FDA’s new regulatory path helps streamline our internal processes and provides us with a consistent approach to making future product enhancement,” president and CEO John Sheridan said. “Customer choice is a core tenet of our company and this clearance supports our commitment to the interoperability of our AID technologies with our current and future insulin pump offerings.”

The t:slim X2 insulin pump with Basal-IQ predictive low glucose suspend technology uses glucose values from a Dexcom G6 continuous glucose monitor to predict and prevent low glucose levels without fingersticks.

Basal-IQ uses CGM values to reduce the frequency and duration of low-glucose events. It predicts glucose levels 30 minutes ahead and stops insulin if they are expected to drop below 80mg/DL or if the CGM reading falls below 70 mg/dL. Insulin delivery starts again when glucose values rise.

Filed Under: Diabetes Tagged With: tandemdiabetes

More recent news

  • Neuronetics names Steven Pfanstiel chief financial officer
  • Medtronic to distribute Future Medical’s peripheral guidewires
  • AtriCure completes enrollment in stroke prevention trial
  • GT Medical raises $53M to support brain tumor treatment
  • Imperative Care, Proximie partner to develop surgical robot to treat stroke

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