EOFlow has filed a 510(k) application with the U.S. Food And Drug Administration (FDA) for its EOPatch, a wearable, disposable insulin patch.
"I am very proud to begin the U.S. clearance process. With this submission, we have taken a major step forward in entering the world's largest diabetes market," EOFlow founder and CEO Jesse Kim said Dec. 27 in a press release. "Furthermore, as the 510(k) device shares a common backplane with all EOFlow products, this submission is an important step in our efforts to commercialize extended wear and closed-loop systems in the U.S."
The 510(k) application demonstrates that the device is safe and effective, but a clearance date has not yet been announced, the company said in a release.
EOPatch was launched in September 2021, and the company has a reported 600 users in Korea, despite the device not being covered by national health insurance. EOFlow officially launched in Europe in September, and in Indonesia in October.
EOFlow announced in November that it had developed a seven-day, wearable pump prototype and was moving it to production. The "EOPatch 3.0" has been called a "next-generation product," which the company is aiming for a 2024 launch.
The current EOPatch, a 2 milliliter reservoir, was the device included in the 510(k) application to the FDA, the company stated in a release.