Tandem Diabetes Care, Inc. announced that the U.S. FDA has classified the t:slim X2 insulin pump as the first in a new device category called Alternate Controller Enabled Infusion Pumps (ACE pumps).
According to the FDA, ACE pumps are devices intended for the infusion of drugs into a patient. The ACE pump may include basal and bolus drug delivery at set or variable rates. ACE pumps are designed to reliably and securely communicate with compatible external devices, such as automated drug dosing systems, to allow drug delivery commands to be received, executed, and confirmed. ACE pumps are intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery.
Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance. The approved indication for the t:slim X2 pump states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices.
“This new classification of the t:slim X2 pump provides more flexibility for us as we make improvements to current products, create new products, and collaborate with best-in-class companies in the development of future automated insulin delivery systems,” said Kim Blickenstaff, president and CEO of Tandem Diabetes Care. “This further establishes the role Tandem Diabetes Care has taken as a key innovator in the insulin pump industry, having launched the first touchscreen pump in the United States, the first pump capable of remote feature updates, the first pump approved as iCGM compatible, and now the first in this new interoperable pump category.”
“The FDA’s special controls set a new standard in our industry and define another component of the regulatory process for future automated insulin delivery systems,” said John Sheridan, executive vice president and COO of Tandem Diabetes Care. “Having the t:slim X2 pump approved with this new designation, combined with its ability for remote software updates, will enable more efficient and predictable development of new systems with current and future technology partners, and allow faster delivery of new innovations to our customers.”