FDA grants De Novo clearance to interoperable insulin pump

The Tandem Diabetes Care t:Slim X2 can work in tandem with other blood sugar management devices, or on its own.
By Dave Muoio
03:18 pm

Last week the FDA granted its first marketing authorization to an interoperable insulin pump that is compatible with automated insulin dosing systems, continuous glucose monitors, blood glucose meters and other diabetes therapy devices built by different manufacturers.

The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of a new medical device category called Alternate Controller Enabled (ACE) infusion pumps. Intended for use by both adults and children with diabetes, the digital device automatically receives insulin dosing commands from a diabetes management device once connected, or can independently infuse insulin when it is on its own.

“Diabetes is a complicated disease that requires close monitoring and carefully tailored treatments,” FDA Comissioner Dr. Scott Gottlieb said in a statement. “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.”

Accompanying the marketing approval was the establishment of new special controls, criteria from the FDA for ACE pump manufacturers regarding the type of studies and quality of data that are necessary to verify a pump’s performance. These generally relate to the devices’ dosing accuracy and reliability, cybersecurity capabilities and fail-safe features — all of which the agency said it considered when evaluating the t:Slim X2 insulin pump.

“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,” John Sheridan, EVP and COO of Tandem Diabetes Care, said in a statement. “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.”

Why it matters

While diabetes patients already have a fairly diverse selection when it comes to devices to manage their blood sugar, compatibility issues between competing manufacturer’s devices keep users from mixing and matching the devices that best suit their individual needs. The FDA’s approval and establishment of special controls not only offers patients a more flexible pump option, but paves the way for future devices with similar compatibilities.

“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 said. “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.” 

What’s the trend

Insulin pumps have become increasingly connected and flexible over the past couple of years — it was just a few months ago that Samsung announced an upcoming integration allowing its Galaxy smartphones to control Insult’s tubeless insulin pump, the Omnipod Dash. But the push toward system interoperability isn’t limited to pumps alone — a paper published just last month described the design, safety and basic efficacy of a reliable, device-agnostic smartphone app able to interface with continuous glucose monitors, insulin pump devices and dosing algorithms from various manufacturers.

On the record

“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,” Kim Blickenstaff, president and CEO of Tandem Diabetes Care, said in a statement. “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 latest news in digital health delivered daily to your inbox.

Thank you for subscribing!
Error! Something went wrong!