AMF Medical receives FDA Breakthrough Device designation for its insulin management system

AMF Medical receives FDA Breakthrough Device designation for its insulin management system

01.12.2021 – AMF Medical based at EPFL Innovation Park, is proud to announce that its Sigi™ Insulin Management System, for diabetes mellitus treatment, has met the criteria and has been granted Breakthrough Device Designation by the US 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. The device 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.

Perspectives for the futur

Antoine Barraud, Co-CEO & Co-Founder of AMF Medical does not hide his gratitude to the FDA for recognizing his 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.”, said Antoine Barraud.

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, PhD from Lausanne University Hospital (CHUV) and principal investigator of the first Sigi™ clinical study.

AMF Medical

Founded in 2014 in the Swiss Medtech Valley, AMF Medical is developing a novel technology to address the unmet needs of people on insulin therapy. The company’s flagship product, Sigi™, is a next-generation, plug ‘n go, semi-reusable and rechargeable patch pump, designed to make life easier for people with diabetes. Sigi™ is intended for prescription-use only and not yet FDA Cleared nor CE-marked. AMF Medical is led by Co-CEOs Mr. Pim van Wesel and Mr. Antoine Barraud, PhD who is also a Co-Founder. Diabetes industry experts John Timberlake and Peter Gerhardsson serve on the company’s Board of Directors.