The FDA has authorized marketing of the first interoperable insulin pump for patients with diabetes, the agency announced on Feb. 14.
The Tandem Diabetes Care t:Slim X2 insulin pump, which delivers insulin under the skin at set or variable rates, can be digitally connected to automatically communicate with and receive drug-dosing commands from other devices. The alternate controller-enabled infusion pump is the first interoperable pump, which means that it can be used with different components of diabetes therapy systems, including automated insulin dosing systems, continuous glucose monitors, blood glucose meters, and other electronic devices.
The FDA reviewed data on dosing accuracy and reliability and assessed the pump's ability to safely communicate with external devices. Risks associated with the pump are similar to those with other infusion pumps and include infection, bleeding, pain, and skin irritations. Incorrect drug delivery could potentially result in hypoglycemia, hyperglycemia, and diabetic ketoacidosis, and loss of communication between devices could pose cybersecurity vulnerabilities, the FDA said.