The FDA is the world's leading medical organization, and it is world recognition that the FDA has chosen the Anyfusion cylinder pump as the world's best, safest and most effective infusion pump, and has even chosen it as STeP. Paradoxically, the existing pump is not suitable as a drug infusion pump because it has serious safety and efficacy problems. Therefore, the FDA has a separate team (Injection Devices Team) for special management and has recommended the development of alternative products, but it is impossible The Anyfusion cylinder pump is the drug infusion pump expected by the FDA and is the only drug infusion pump out of 14 items selected as STeP.
 
We need to submit data for FDA 510K certification and enrolment in the US insurance system, but it is not logical and unreasonable that the cylinder cartridge is limited to selective payment for care services above 5ml/hr, which is interpreted as logic that 5ml/hr is safe and valid, but 5ml/hr is unsafe and ineffective, so we cannot submit data. Furthermore, it is not the role and duty of our government to allow unsafe and ineffective equipment to be used for Korean patients and all patients around the world. Allowing unsafe and ineffective devices to continue to be used to administer any drug at any dose to critically ill patients is a compromise of patient safety, health and life that should not be allowed to continue.
For this reason, it is judged that the cylinder cartridge has the conditions to be adjusted from a selective benefit to a general benefit (nursing benefit), and that it will be positively reviewed as a matter of time with the addition of a more certain FDA STeP selection. In addition, regardless of the IRA, it is judged that there will be cooperation from the government (Health North Branch) for FDA certification and global export to the United States. We believe that the Ministry of Health and Welfare will make a wise decision for the safety of patients in order to overcome the export slump and achieve $16 billion in medical device exports in the face of poor export conditions such as IRA.

Thank you.