The FDA announced this week that it established Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump as the first in a new category of devices called ‘Alternate Controller Enabled Infusion Pumps’ or ACE pumps.
The newly-approved indication for Tandem’s t:slim X2 pump clears the device to communicate with compatible products, including insulin dosing software and continuous glucose monitors.
Thanks to its new classification, the t:slim X2 system can deliver insulin to patients either via dosage commands from other diabetes management devices or on its own.
“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. Advances in digital health make more tailored approaches to diabetes care possible,” FDA chief Dr. Scott Gottlieb said in prepared remarks.
“The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized 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,” Gottlieb added. “Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology.”
“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,” Tandem president & CEO Kim Blickenstaff said in a statement.