FDA OKs first interoperable insulin pump with new classification
The Tandem Diabetes Care t:Slim X2 has been approved by the Food and Drug Administration to deliver insulin under the skin for diabetic patients.
According to the FDA, the device is a new type of insulin pump—called an alternate controller enabled (ACE)—that leverages interoperable technology and can be used with different components of other diabetes therapy systems, enabling patients to tailor diabetes management to their individual device preferences.
For instance, the device can be digitally connected to automatically communicate with and receive drug dosing commands from other diabetes management devices—such as automated insulin dosing systems—or can be used to infuse insulin on its own.
“Advances in digital health make more tailored approaches to diabetes care possible,” said FDA Commissioner Scott Gottlieb, MD, in a written statement. “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.”
In the past, insulin pumps have either been cleared by the FDA as stand-alone devices (class II, moderate risk devices) or approved by the FDA as part of a single predefined diabetes management system (class III, highest-risk devices). However, because the t:Slim X2 is interoperable with other diabetes device components, the device was reviewed through the de novo premarket review—a regulatory pathway for novel, low- to moderate-risk devices of a new type.
In addition, the FDA has created criteria—called special controls—to ensure the accuracy, reliability, cybersecurity and clinical relevance of ACE infusion pumps, as well as establishing a new regulatory classification for this type of device.
“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,” added Gottlieb. “We’re committed to advancing new ways to accelerate the development of innovations that can improve patient care while strengthening our pre- and post-market tools for determining the safety and effectiveness of these new technologies.”
According to Tandem Diabetes Care, the t:slim X2 insulin pump includes a large color touchscreen, rechargeable battery, Bluetooth wireless technology and USB connectivity, as well as the ability to conduct remote software updates using a personal computer.
“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,” says 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.”