Tandem wins interoperable claim for insulin pump from FDA

The FDA announced this week that it established Tandem Diabetes Care‘s (NSDQ:TNDM) t:slim X2 insulin pump as the first in a new category of devices called ‘Alternate Controller Enabled Infusion Pumps’ or ACE pumps. The newly-approved indication for Tandem’s t:slim X2 pump clears the device to communicate with compatible products, including insulin dosing software and continuous glucose monitors. Get the full story at our sister site, Drug Delivery Business News. The post Tandem wins interoperable claim for insulin pump from FDA appeared first on MassDevice.
Source: Mass Device - Category: Medical Devices Authors: Tags: Diabetes Drug-Device Combinations Featured Food & Drug Administration (FDA) Pharmaceuticals Regulatory/Compliance Wall Street Beat tandemdiabetes Source Type: news