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 technology partners, and allow faster delivery of new innovations to our customers.”
Insulin pumps to date have either been cleared by FDA as stand-alone devices (class II, moderate risk devices) or approved by the agency as part of a single, predefined diabetes management system (class III, highest-risk devices). Because the interoperable t:Slim X2 insulin pump is interoperable with other diabetes device components, the pump was reviewed through the de novo premarket review pathway.
“The marketing authorization of the first ACE insulin pump intended for interoperable use has the potential to aid patients who seek more individualized diabetes therapy systems and opens the door for developers of future connected diabetes devices to get other safe and effective products to patients more efficiently,” Scott Gottlieb, M.D., FDA Commissioner, said in a release. “Because the FDA’s action creates a new regulatory classification, future ACE insulin pumps will be able to go through the more efficient 510(k) review process, helping to advance this innovative technology.”
Other Significant Developments in Diabetes
Diabetes management remains one of the hottest and fastest growing markets in medtech. The space has been a relative gold mine for companies seeking to get an entry point into healthcare.
Verily (Google’s former life sciences division) solidified its presence in healthcare through numerous partnerships to develop diabetes treatment and monitoring devices.
Beta Bionics, (Reader’s choice for the Medtech Company of the Year), has been making significant strides in the diabetes space. The company received an IDE for its artificial intelligence-driven bionic pancreas – the iLet.
However, one of the most significant changes in recent history to impact the diabetes market occurred when Senseonics was awarded a PMA for the Eversense implantable continuous glucose monitoring system.