Mini, AP Patch Given FDA Nod for Fast-Track Review

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.

The device was created by EOFlow, a company based in South Korea, and the technology was funded in part by JDRF as the organization continues to advocate for and support greater choice and management of care for the T1D Community.

The device — called the EOPancreas system – is a closed-loop Automated Insulin Delivery /Artificial Pancreas Device (AID/AP).

It features 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.

EoFlow says its system will 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.

“EOFlow was founded to democratize wearable drug delivery solutions by providing intelligent, connected solutions for patients managing chronic conditions at globally-competitive price points,” said  Jesse Kim, founding CEO of EOFlow. “We see the Breakthrough Device designation as an important validation of our business model.”

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.