Another Significant Milestone in the Diabetes Space

Tandem Diabetes Care has been given FDA approval for its t:slim X2 insulin pump. Through the approval, the agency has created a new device category – Alternate Controller Enabled Infusion Pumps (ACE Pumps). The San Diego-based company’s recent approval joins the list of several developments that have changed or helped reshape the diabetes market. Along with this authorization, the FDA is establishing criteria, called special controls, which outline requirements for assuring the accuracy, reliability, cybersecurity and clinical relevance of ACE pumps, as well as describe the type of studies and data required to demonstrate acceptable pump performance. The approved indication for the t:slim X2 pump states that the pump is able to reliably and securely communicate with compatible, digitally connected devices, including automated insulin dosing software, to receive, execute, and confirm commands from these devices. “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, executive vice president and COO of Tandem Diabetes Care, said in a release. “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 t...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Regulatory and Compliance Source Type: news