FDA Approves First Customizable Insulin Pump

Share this content:
FDA Approves First Customizable Insulin Pump
FDA Approves First Customizable Insulin Pump

FRIDAY, Feb. 15, 2019 (HealthDay News) -- The Tandem Diabetes Care t:Slim X2 insulin pump, which allows a patient to customize treatment, has been approved by the U.S. Food and Drug Administration.

The new device is described as either an alternate controller enabled (ACE) infusion pump or an interoperable pump, so it can be used with different components that allow users to tailor diabetes management to their preferences, according to the agency. The product works by delivering insulin under the skin at set or variable rates. It can be digitally connected to automatically communicate with and receive drug-dosing commands from other diabetes-management devices.

Along with this approval, the FDA said it is establishing "special controls" that define requirements for ensuring the accuracy, reliability, and cybersecurity of ACE infusion pumps. These controls also describe the type of studies and data required to demonstrate acceptable performance. Potential side effects of the newly approved device include infection, bleeding, pain, skin irritation, and blockages and air bubbles in the tubing, the agency said.

"Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments. We've heard from the patient community that having the ability to customize their own diabetes management devices is important to them," FDA Commissioner Scott Gottlieb, M.D., said in a statement. "Advances in digital health make more tailored approaches to diabetes care possible."

The product is made by Tandem Diabetes Care, based in San Diego.

More Information

Share this content:

is free, fast, and customized just for you!




Already a member?

Sign In Now »

Trending Activities

All Professions

Drug Lookup

Browse drugs by: BrandGenericDisease

More in Home

CDC: Progress in HIV Prevention Has Stalled in the United States

CDC: Progress in HIV Prevention Has Stalled in ...

Agency says effective HIV prevention, treatment not reaching those who could most benefit

AAAAI: Egg Oral Immunotherapy Shows Sustained Benefit in Children

AAAAI: Egg Oral Immunotherapy Shows Sustained Benefit in ...

All children with sustained unresponsiveness ingested concentrated and baked egg

Prenatal Vitamin Intake in Early Pregnancy May Cut Autism Risk

Prenatal Vitamin Intake in Early Pregnancy May Cut ...

ASD risk down for children whose mothers took prenatal vitamins during first month of pregnancy

is free, fast, and customized just for you!




Already a member?

Sign In Now »