AnyFusion has been granted Safer Technologies Program (STeP) designation for the first time in Korea on October 25.

Since the existing drug injection pumps Infusion Pump and Syringe Pump were developed and had the most problems with safety and effectiveness among existing medical devices for more than 70 years, we found out that the FDA has created a separate injection device team for tens of thousands of medical accidents.

As we conducted the STeP, we learned that the FDA Injection Devices Team as well as the UL (Emergo) officials who consulted were the top experts in the drug injection pump. The safety and effectiveness of the existing pump proposed by officials of the two organizations who understood the principle and concept of Anyfusion Cylinder pump were confirmed to be completely solved through STeP with Anyfusion source technology, and it was selected as the first STeP outside the United States.

We hope that our Anyfusion product will be certified as 510K and used safely and effectively for patients to contribute to treatment, as well as the Injection Devices Team, a special management department. Anyfusion cylinder pump, which solves safety and effectiveness problems, has contributed significantly to saving medical expenses such as medical accidents, early treatment and discharge, work load reduction, and death volume.

We are given the right to prioritize FDA 510K certification by selecting FDA STeP, so we can obtain certification as soon as possible by using CE certification data and SCI clinical trial papers. And when we get into the U.S. market, we expect to gain significant momentum in rapid marketization.

Due to our designation of STeP, we have gained momentum in entering the market with the safety and effective competitiveness recognized by FDA, the world's top certification body, in other continents other than FDA 510K certification rights. In particular, Japan, advanced countries in Europe, and the Middle East are conducting certification to enter the Anyfusion market.

The government is also considering fostering our companies strategically and with policy. 

Thank you for your efforts and cooperation in the FDA official director, UL (Emergo) consultant.