FDA clears Tandem Diabetes Care new pump

14 February 2019

The US FDA has granted marketing clearance for the Tandem Diabetes Care’s pump, which can deliver insulin under the skin in both children and adults. This is the first device to be released within the new alternate controller enabled infusion pumps (ACE pumps) category.

It features an interoperable technology which enables use with various components of diabetes therapy systems. This can include an ACE insulin pump and other compatible medical devices such as automated insulin dosing (AID) systems and continuous glucose monitors (CGMs). These capabilities allow diabetes management to be tailored based on individual preferences.

“The device delivers insulin at set or variable rates and can digitally connect with other diabetes management devices for automatic communication and to receive drug dosing commands,” said Tandem Diabetes Care.

“The marketing authorisation of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualised diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently,” said FDA commissioner Scott Gottlieb.

The FDA reviewed performance data from the device and showed accurate and reliable dosing of insulin at the rates and volumes programmed by the user. They also evaluated the ability of the pump to communicate with external devices with suitable reliability, cybersecurity and fail-safe modes.

Currently, the FDA is developing criteria called special controls that outline requirements for validating the accuracy, reliability, cybersecurity and clinical relevance of ACE infusion pumps.

In addition, this guidance will provide information on the type of studies and data needed to demonstrate the acceptable performance of the pumps.

Diabetes is just one of the many different chronic diseases that is witnessing an increase in technological treatments for the condition. Some of the other latest medical devices for diabetes include high-tech insulin pens, management apps and glucose monitors.



Privacy Policy
We have updated our privacy policy. In the latest update it explains what cookies are and how we use them on our site. To learn more about cookies and their benefits, please view our privacy policy. Please be aware that parts of this site will not function correctly if you disable cookies. By continuing to use this site, you consent to our use of cookies in accordance with our privacy policy unless you have disabled them.