KORU Medical Systems, Inc. Submits 510(K) Application for Freedom60® Infusion System with Hizentra® 50 mL Prefilled Syringes

Monday, July 10, 2023

KORU Medical Systems, Inc. has announced the submission of a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for its FREEDOM60® Infusion System with Hizentra® 50 mL prefilled syringes. The company is focused on developing, manufacturing, and commercializing specialty subcutaneous infusion solutions that improve patients' quality of life.

The submission of the 510(k) application represents a milestone in KORU Medical's mission to simplify and enhance subcutaneous therapy for patients. The combination of the FREEDOM60 Infusion System with Hizentra 50 mL prefilled syringes aims to benefit patients who self-administer subcutaneous immunoglobulin treatment at home. The use of prefilled syringes can significantly reduce drug preparation tasks for patients, providing a more convenient and efficient treatment experience.

KORU Medical's President and CEO, Linda Tharby, emphasized the company's commitment to delivering innovative solutions that improve the patient experience. The FDA's approval of the 50 mL Hizentra prefilled syringe in April 2023 further supports the adoption of this advanced delivery method for subcutaneous immunoglobulin therapy.

KORU Medical is dedicated to simplifying subcutaneous therapy and enhancing patient outcomes. The submission of the 510(k) application represents another step forward in their efforts to provide accessible and user-friendly solutions for home subcutaneous therapy.

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