South Korean wearable drug delivery systems provider EOFlow has submitted a 510(k) application to the US Food & Drug Administration (FDA) for its wearable disposable insulin pump EOPatch with a reservoir size of 2ml.
With the EOPatch disposable wearable insulin pump, EOFlow plans to enter the US diabetes market.
The firm officially launched EOPatch in Europe in September this year. It also secured UAE’s approval in September 2022, and Indonesia’s approval in October 2022.
EOFlow said that the 510(k)-filing move aligns with its global expansion plan.
EOFlow founder and CEO Jesse Kim said: “I am very proud to begin the US clearance process. With this submission, we have taken a major step forward in entering the world’s largest diabetes market.
“Furthermore, as the 510(k) device shares a common backplane with all EOFlow products, this submission is an important step in our efforts to commercialise extended wear and closed loop systems in the US.”
According to an EOFlow official, the expected clearance date is still unknown. The commercial launch plan with its potential partner will depend on the FDA clearance schedule.
In November this year, the firm developed a production-ready seven-day wearable pump prototype. EOFlow announced that the EOPatch 3.0 is the next-generation product aiming for a 2024 launch.
The pump completed various tests with the samples that have a 3ml reservoir and can work for seven days using on EOFlow’s ultra-low-power, high-performance pumping technology.
The Korean firm also has a Breakthrough Device Designation from the US health regulator for a wearable integrated artificial pancreas solution. It is claimed as a wearable disposable device that consists of a glucose monitoring sensor, an insulin pump and an automated insulin delivery algorithm.
EOFlow is currently in talks with potential US distributors and plans to ink the distribution agreement within the first half of 2023.
