FDA grants de novo clearance to Tandem’s plug-and-play insulin pump

FDA Building
The agency also established new criteria outlining the accuracy, reliability and cybersecurity requirements of future interoperable infusion pumps. (FDA)

The FDA has approved a new type of insulin pump that can be used with different components from other diabetes therapy systems.

Tandem Diabetes Care’s t:Slim X2 pump—which the agency described as the first in a new category of interoperable hardware, called alternate controller-enabled infusion pumps, or ACE pumps—allows patients to tailor their diabetes management by linking their preferred devices, including compatible automated dosing systems, continuous glucose monitors and blood sugar meters.

“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,” said FDA Commissioner Scott Gottlieb in an agency statement.


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And because of the new regulatory classification and de novo clearance, future interoperable insulin pump developers will be able to go through a faster 510(k) process, Gottlieb added. Previously, the FDA has cleared insulin pumps as standalone, Class II devices or approved as part of a predefined, Class III diabetes management system.

RELATED: Tandem unveils free software update for predictive glucose tracking and insulin delivery

With the de novo clearance, the FDA established new special control criteria, outlining the requirements for accuracy, reliability, cybersecurity and clinical relevance of ACE infusion pumps, as well as the types of studies and data required.

The pump itself features a color touchscreen, rechargeable battery, Bluetooth wireless technology, USB connectivity and watertight construction, and holds up to 300 units of insulin.

“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,” Sheridan added.

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