FDA Breakthrough Device Designation for EOPancreas

The EOPancreas, received Breakthrough Device Designation by the FDA which grants priority review to companies with promising, breakthrough technology for those living with chronic conditions. The EOPancreas will combine a continuous glucose monitor (CGM) with a tubeless, patch insulin pump (similar to the Omnipod). Running on artificial intelligence (AI) algorithms on a private cloud system (EOCloud), the system adapts to each individual user to learn routines, insulin-to-carb ratios, exercise habits, typical food choices and diet, sleep, hormones, and more to automate the best possible control. The system consists of the following parts:

• EOCloud technology with AI alogrithms to learn and meet the needs of every user
• Tubeless, patch pump (waterproof) that holds 200 units of insulin and lasts for 72 hours (disposable after each use)
• CGM that will communicate directly with the patch pump (the company has reached an agreement with China-based POCTech)
• An Advanced Diabetes Manager (ADM) in the form of a smartphone-like device that can save up to 8 basal and bolus preset programs. This device keeps track of glucose trends, insulin delivery history, carbohydrate and exercise history, and can track abnormalities such as occlusions or low battery levels.

The EOPancreas System is being developed through financial support from the JDRF and is expected launch in 2021.

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