OSAKA, Japan, July 30, 2026 /PRNewswire/ — NIPRO CORPORATION has been granted 510(k) clearance for the ELISIO-HX dialyzer by the United States Food and Drug Administration (FDA), effective July 28, 2026. The clearance enables the introduction of HDs (Hemodialysis powered by super high-flux membrane) in the United States. HDs is NIPRO’s approach within expanded hemodialysis (Expanded HD), providing healthcare professionals with a practical way to enhance hemodialysis while using existing dialysis infrastructure and established clinical workflows.

Hemodialysis remains the cornerstone of treatment for patients with end-stage kidney disease in the United States. Although treatment standards continue to evolve, there remains an ongoing need to improve the removal of a broader range of uremic toxins, including larger middle molecules that have been associated with chronic complications of kidney disease. ELISIO-HX has been developed to address this need through an approach designed for broad patient eligibility and straightforward integration into routine dialysis care.