SFC Fluidics, a JDRF Partner, Receives Breakthrough Device Designation
Last month, SFC Fluidics received a breakthrough device designation for the company’s interoperable insulin delivery pod from the Food and Drug Administration (FDA). The product is in late-stage development and submission for clearance is expected in 2021. The development of SFC’s interoperable pump was partly funded by JDRF.
How is the SFC interoperable pump different than other insulin pumps?
SFC Fluidics’ Chief Executive Officer, Anthony Cruz, tells us that the primary goal for SFC’s product development is to empower people with diabetes; to use their cutting-edge microfluidics technology to make things easier and better for the individual.
Two Simple Questions
The Company’s engineers and scientists were challenged with two simple questions, “How do we make the person forget about his/her diabetes?” and “How do we ease the burden of diabetes?”
Insulin pumps currently in use can fall short in dosing accuracy. SFC believes that insulin dose inaccuracy leads to inconsistent diabetes management. Furthermore, current pumps can also fall short in alerting the person of no or low insulin-flow errors—unnecessarily putting millions of people with insulin-dependent diabetes at risk.
SFC’s pump is designed to be safe and deliver highly precise insulin doses. Its pod technology can detect flow or no flow conditions of insulin in real-time, even in extremely small doses.
SFC believes its technology will effectively eliminate 95 percent of over and under dispenses of insulin. The end result promises to be a significant “step up” in peace of mind that the person is safe and can focus on living their lives.
The Breakthrough Device Program is an FDA platform for more effective treatments of serious diseases, like T1D, and enables timely access to these devices by speeding their development, assessment, and review. Other companies that have received the FDA Breakthrough Device designation for T1D technologies include JDRF partners EOFlow, Medtronic, and Bigfoot.
Its safety and exceptional dose accuracy are promising features of SFC’s interoperable insulin delivery pod, and JDRF applauds SFC on this special honor.
Learn more about how you can support JDRF and their work to prevent, treat, and—one day—find cures for T1D.