-Craig Idlebrook

A closed-loop patch insulin pump/CGM system has been granted FDA Breakthrough Device Designation by the FDA. The designation is designed to provide a faster track to FDA approval for devices that are considered to provide novel treatment options.

EOFlow, a company based in South Korea, is developing the closed-loop pump system. Dubbed the EOPancreas system, it would feature a disposable, integrated patch insulin pump. On its website, EOFlow bills its patch pump as the “smallest, lightest, safest” pump; it also characterizes the device as waterproof.

The system would include a special wearable continuous glucose monitor sensor (CGMS) – a wearable and disposable module that combines both the sensor and controller. Users would not need additional fingersticks to validate CGMS readings once the sensor is validated, according to the website’s promotional materials.

The EOPancreas would utilize a proprietary artificial intelligence algorithm, called EOCloud, to automate insulin delivery. Pump users would be able to control basal and bolus delivery through a touchscreen interface on a special controller running on an Android system. Currently, the first version of this pump system does not have a low-glucose suspend feature, according to the company’s website.

These statements made by the company about the pump system have not been validated by the FDA, as the device has not come before federal health regulators for approval.

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This is a second important milestone for the relatively new company. In 2017, JDRF announced that it had provided EOFlow funding to develop its pump system. In the announcement, JDRF officials said that the pump system could provide a less bulky closed-loop pump system option than those currently on the market, and that could benefit to children with type 1 diabetes. Currently, the only approved closed-loop insulin pump system on the market is the Medtronic 670G.

The Breakthrough Device Designation is an important mark of validation by the agency, one likely to help EOFlow sell its pump system to investors and move closer to bringing the pump system to market.

To read the full press release on the designation, click here.