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AMF Medical’s Sigi Insulin System Designated an FDA Breakthrough Device

December 3, 2021

Switzerland-based AMF Medical has been granted the FDA’s Breakthrough Device designation for its Sigi insulin management system.

The insulin patch pump, which is for use with standard, pre-filled pump cartridges, can be programmed to deliver basal and bolus insulin at both set and variable rates.

In addition, it can execute and confirm dosing commands by interacting with Bluetooth-compatible, continuous glucose monitors and alternate controller devices, such as a smartphone, the company said.

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