FDA Grants Breakthrough Device Designation to Insulin Patch Pump


The ergonomic device for the treatment of diabetes is the only insulin patch pump for closed loop integration able to be used with standard, pre-filled pump cartridges.

The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Sigi Insulin Management System for the treatment of diabetes.

The system is the only insulin patch pump for closed loop integration currently designed for use with standard, pre-filled pump cartridges. Breakthrough Device Designation for the system was granted to AMF Medical.

Research showed the insulin management system can be programmed to deliver both basal and bolus insulin at both set and variable rates.

It was additionally noted that due to being an Alternate Controller Enabled-pump, the device can receive, execute and confirm dosing commands through a Bluetooth-compatible continuous glucose monitor and alternate controller device, including a smartphone or iController.

The company also explained that the insulin management device is smaller, lighter, and more convenient that current insulin delivery systems, due to an ergonomic design that accommodates standard, insulin pre-filled pump cartridges.

In a statement, Antoine Barraud, AMF Medical Co-CEO and Co-Founder, shared his thanks to the FDA for recognizing the patient-focused device, which works to provide the patients 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,'' he said. “It is a huge step forward in bringing Sigi to market to improve insulin management."

Additionally, the statement included remarks from Anne Wojtusciszyn, MD, PhD Lausanne University Hospital (CHUV) and the principal investigator of the first Sigi clinical study on the ease of using the device, backed up from the clinical data.

Study patients have expressed satisfaction as well as eagerness for this next generation patch to be readily available,” Wojtusciszyn said. “We are pleased that the FDA also sees its clear value and is moving the process forward.”

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