EOFlow Submits 510(k) Application for Disposable Insulin Patch

South Korea-based EOFlow has submitted a 510(k) application to the FDA for its EOPatch, a wearable, disposable insulin pump for diabetes patients.

The patch-type pump is placed on the skin and holds 2 mL of insulin. The tubeless pump can be used for three and a half days, the company said.

EOFlow is seeking the FDA’s clearance to launch the device in the U.S. — the world’s largest diabetes market with an estimated 37.3 million diabetics. The patch is already approved in South Korea, Europe, the United Arab Emirates, and Indonesia.