AMF Medical has secured the US Food and Drug Administration (FDA) Breakthrough Device Designation for its Sigi Insulin Management System to treat diabetes mellitus.

The Swiss medical equipment manufacturer designed Sigi as a plug and play, semi-reusable and rechargeable patch pump, to aid people with diabetes.

It can accommodate standard insulin pre-filled pump cartridges and can be programmed to deliver basal and bolus insulin at both set and variable rates.

Sigi is an alternate controller enabled pump that connects with Bluetooth-enabled CGMs, smartphones or iController devices, to receive, execute and confirm dosing commands.

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 prioritise its review in future FDA regulatory submissions. It is a huge step forward in bringing Sigi to market to improve insulin management.”

Sigi works with a bubble-free pumping mechanism, and eliminates the need for warming up of the insulin, and filling reservoirs with a syringe, as it uses prefilled insulin cartridges.

It is the smallest, lightest patch pump, with superior user experience, where 80% of current patch pump users would shift to Sigi, said the company.

Sigi prototypes were tested in real-life conditions over two weeks, in collaboration with the CHUV university hospital in Lausanne, Switzerland.

According to clinical trial data, Sigi is easy to use, and the participants expressed satisfaction and eagerness for the next generation patch.

The company noted that Sigi is intended for prescription use only and has not yet received the US Food and Drug Administration (FDA) or CE Mark approval.

Established in 2014, AMF Medical is engaged in developing a novel technology to address the unmet medical needs of people on insulin therapy.