It’s breaking new ground and gives patients more control.
To date, the U.S Food and Drug Administration has approved two types of devices for managing diabetes: those that are stand-alone devices, and those that are part of a single, predefined management system. If you wanted to combine various devices to form your own unique system, you did so at your own peril.
But times have now changed.
The Tandem Diabetes Care t:Slim X2 insulin pump has just broken new ground. Approved mid- February by the administration for marketing, this ACE insulin pump is the first to be used with different components from various diabetes therapy systems.
For patients, this could be a real gem. Basically, it means that you can now tailor your own diabetes management to your preferences, and combine the devices to do so that suit you best.
Sound easy? Sort of. In order to make this step, the FDA had to create a new regulatory classification. This means that new criteria has been outlined with regards to requirements that need to be met by this pump and future models. These controls will ensure accuracy, reliability, cybersecurity and clinical relevance when the devices are in use.
The good news is that this will allow future ACE insulin pumps that comply with this criteria to go through a more efficient premarket review with the FDA. Consumers will have more choice, and sooner.
Nearly 10 percent of Americans are diagnosed with diabetes and can’t make or properly use their own insulin. For more information on this pump, click here.