Tandem’s Mobi Approved by the FDA

Product Development & Management

Tandem’s Mobi Approved by the FDA

By |

Tandem’s Mobi Approved by the FDA

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article, sourced from Beyond Type 1, titled “Tandem’s Mobi Approved by the FDA” – originally written by Christine Fallabel and published on July 11, 2023.

Tandem’s Mobi Approved by the FDA

On Tuesday, July 11th, 2023, the Food and Drug Administration (FDA) announced the approval of Tandem’s newest insulin pump, called Mobi. This insulin pump is fully controllable from a mobile app and is now the world’s smallest durable automated insulin delivery system.

THE MOBI INSULIN PUMP

The Mobi will join a growing selection of Tandem products that support people with diabetes. Their human-centered approach to design, develop and support innovative products and services for people who use insulin is evident in this latest approval.

John Sheridan, president and chief executive officer for Tandem Diabetes Care said, “Through this expansion, we are delivering on our commitment to bring greater choice, along with the proven benefits of Tandem’s technology, to more people living with diabetes.”

The San Diego-based company also manufactures the T:Slim X2 insulin pump with Control-IQ technology, a feature that is also part of this new release.

Control-IQ technology utilizes compatible continuous glucose monitor (CGM) sensor readings to predict blood sugar levels 30 minutes ahead of time. It then adjusts insulin delivery every five minutes to help prevent both high and low blood sugars levels. The system also delivers automatic correction boluses of insulin for up to an hour to help prevent high blood sugars.

The user can still manually bolus for snacks and meals.

The Mobi has been approved for people with diabetes aged six and older who require insulin.

RELATED: Failure Modes, Effects, and Diagnostic Analysis (FMEDA) for Medical Devices: What You Need to Know

MOBI FEATURES

The new Mobi has some great features that will make pumping not only easier for people, but more convenient and flexible too.

  • 200-unit insulin cartridge
  • Less than half the size of the T:Slim X2 pump
  • Detachable infusion sets that are compatible with all existing Tandem infusion sets, allowing users to mix and match infusion sites and tubing length combinations for greater flexibility
  • Control IQ technology designed for use as part of an automated insulin delivery system
  • Mobile app control with an on-pump button, providing an option for the user to utilize phone control for bolusing insulin
  • Inductive charging and capable of wireless remote software updates from a compatible smartphone

MORE CHOICES FOR PEOPLE WITH DIABETES

This new approval will greatly expand the choices people with diabetes who use insulin pumps will have, and it is the smallest and most convenient insulin pump yet.

According to the manufacturer, the Mobi is small enough to fit in a coin pocket, be clipped to clothing or fit into an adhesive sleeve—expanding where and how and insulin pump fits into your life and lifestyle.

Additionally, the Mobi insulin pump is completely controllable from a user’s mobile phone via an app, a feature many people with diabetes are looking for in newer tech releases.

People don’t want to always be juggling multiple devices, and having both blood sugar readings and insulin pumping capability from a smartphone just makes life with diabetes easier.

RELATED: Elevating Your Medical Device and Life Sciences Product Development Processes with Jama Connect®

MARKET AVAILABILITY COMING SOON

A limited release is expected to start in late 2023 with full commercial release planned for early 2024. To sign up for updates, please visit tandemdiabetes.com/mobi.

If you are interested in trying the Mobi insulin pump when it is available, start talking to your provider now about any necessary steps you may need to take like getting a prior authorization.


Jama Software
Latest posts by Jama Software (see all)