The US FDA authorises marketing of first interoperable insulin pump to allow patients to customise treatment through individual diabetes devices.
M2 PHARMA-February 15, 2019-The US FDA authorises marketing of first interoperable insulin pump to allow patients to customise treatment through individual diabetes devices
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Public health agency The U.S. Food and Drug Administration Thursday granted approval of the marketing of the Tandem Diabetes Care t:Slim X2 insulin pump with interoperable technology (interoperable t:Slim X2) for delivering insulin for children and adults with diabetes, through the de novo premarket review pathway.
The US FDA announced the marketing authorisation of the t:Slim X2 insulin pump with the interoperable technology to Tandem Diabetes Care Inc.
Based on the review of the interoperable t:Slim X2 pump performance data, the device can dose insulin accurately and reliably and at the rates and volumes programmed by the user. The US FDA assessed the ability of the pump to communicate with external devices with appropriate reliability, cybersecurity and fail-safe modes.
Additionally, the company's interoperable t:Slim X2 pump works by delivering insulin under the skin at set or variable rates. It can be digitally connected to automatically communicate with and receive drug dosing commands from the AID systems, which typically consist of a pump CGM and software to control the system.
According to the agency, the new the Tandem Diabetes Care t:Slim X2 insulin pump is the first interoperable pump that allows patients to tailor their diabetes management to their individual device preferences.Diabetes therapy systems may be comprised of an ACE insulin pump and other compatible medical devices, including automated insulin dosing (AID) systems, continuous glucose monitors (CGMs), blood glucose meters or other electronic devices used for diabetes management.
Nearly 10% of Americans are diagnosed with diabetes, which impairs the body's ability to make or properly use the blood glucose-regulating hormone insulin.
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|Date:||Feb 15, 2019|
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