AMF Medical announced today that it received FDA breakthrough device designation for its Sigi insulin management system.
Ecublens, Switzerland-based AMF Medical’s Sigi (for diabetes mellitus treatment) can be programmed to deliver basal and bolus insulin at both set and variable rates.
Sigi, an alternate controller-enabled pump, can receive, execute and confirm dosing commands through interactions with Bluetooth-compatible continuous glucose monitors (CGMs) and alternate controller devices including smartphones and iControllers, according to a news release.
AMF Medical touts Sigi as smaller, lighter and more convenient than current insulin delivery systems through its ergonomic design that accommodates standard, pre-filled insulin pump cartridges.
Dr. A. Wojtusciszyn of Lausanne University Hospital, the principal investigator of the first Sigi clinical study, said in the release that the pump is “delightfully easy to use” as study patients have been satisfied and expressed eagerness for the next-generation patch to be readily available.
“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,” AMF Medical Co-CEO & Co-Founder Antoine Barraud said in the release. “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.”