iLet Bionic pancreas system gets FDA Breakthrough Device

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The Food and Drug Administration of the US has granted “ Breakthrough Device” designation to iLet Bionic pancreas system, a wearable device designated to control blood sugar levels in diabetic patients.

Breakthrough designation is for accelerating regulatory review of a therapy that is considered to have the potential to address unmet medical needs. Beta Bionics president and CEO Edward R Damiano was quoted in the media as saying that iLet Bionics system was a breakthrough therapy for management of glycaemia, especially in type 1 diabetic patients.

iLet is pocket sized wearable device that autonomously control glucose levels. It is similar to an insulin pump. Unlike Insulin pump, the company said that there was only need to enter body weight for bionic pancreas to initialise therapy. There was no need to count carbohydrates or set insulin delivery rates or any corrections in between.

The bionic pancreas functions as three medical devices in one, the company said. It can be configured as an insulin only bionic device or a bihormonal bionic device using insulin and glucagon or a glucagon only bionic.

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