EOFlow is seeking approval from the US Food and Drug Administration (FDA) for its wearable disposable insulin pump, EOPatch.
The company has submitted a 510(k) application to the regulator for the disposable insulin pump to enter the US market.
EOPatch insulin pump was launched in Korea in April last year.
In September this year, the company introduced this wearable disposable insulin pump in Europe.
EOFlow also secured approval for the pump in UAE during the same month, while in Indonesia in October.
At present, the company is negotiating terms with the US distributors and plans to sign a distribution agreement within the first half of next year.
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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.”
Last month, the company stated that it had developed the prototype of a seven-day wearable pump and advanced it to productisation.
The next-generation ‘EOPatch 3.0’, which is expected to be launched in 2024, has been evaluated in various tests with samples that have a 3ml reservoir. It can be operated for seven days based on EOFlow’s pumping technology,
The ‘EOPatch’, which is currently filed to the FDA, has a reservoir size of 2ml.
Furthermore, the company already received breakthrough device designation from FDA for a wearable integrated ‘artificial pancreas‘ solution.
It is a wearable disposable device that features a glucose monitoring sensor, an insulin pump and an integrated automated insulin delivery algorithm.