Sigi™ provides a modern solution in the treatment of diabetes mellitus. It is the only insulin patch pump for closed loop integration designed for use with standard, pre-filled pump cartridges. Sigi™ can be programmed to deliver basal and bolus insulin at both set and variable rates via a Bluetooth-compatible continuous glucose monitors or alternative controller devices such as a smartphone or an iController.
“We would like to thank the FDA for recognizing our team’s proprietary, patient-focused technology, which provides users with enhanced clinical and convenience features. This Breakthrough Device Designation will expedite the development of Sigi™ and prioritize its review in future FDA regulatory submissions. It is a huge step forward in bringing Sigi™ to market to improve insulin management.”
Breakthrough Device Designation offers the opportunity to get lifesaving or life-improving medical devices out in the world where they can make a positive impact on a patient population in a quick and efficient manner. The submission process for BDD runs on a 60-day timeline.
Click here to read more about AMF Medical’s Breakthrough Device Designation for their Sigi™ Insulin Management System.
To learn more about BDD and how Proxima Clinical Research can assist you in getting your product Breakthrough Device Designation, reach out to a regulatory specialist that can get your product on the path to market.