AMF Medical’s Sigi insulin management system for diabetes mellitus treatment has met the criteria and has been granted Breakthrough Device Designation by the U.S. Food and Drug Administration.
 
Sigi can be programmed to deliver basal and bolus insulin at both set and variable rates. In addition, as an Alternate Controller Enabled-pump, it is able to receive, execute and confirm dosing commands by interacting with Bluetooth-compatible, continuous glucose monitors and alternate controller devices, like a smartphone or an iController.
 
Sigi is also smaller, lighter, and more convenient than current insulin delivery systems. This is made possible by its ergonomic design, which accommodates standard, insulin pre-filled pump cartridges.
 
AMF Medical Co-CEO and co-founder Antoine Barraud said: "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."
 
"Clinical study data has shown that Sigi is delightfully easy to use. Study patients have expressed satisfaction as well as eagerness for this next generation patch to be readily available. We are pleased that the FDA also sees its clear value and is moving the process forward," said Professor A. Wojtusciszyn, MD, Ph.D. from Lausanne University Hospital (CHUV) and principal investigator of the first Sigi clinical study.