Shots:
- NIPRO CORPORATION received US FDA 510(k) clearance for its ELISIO-HX dialyzer, enabling the US commercialization of HDs (Hemodialysis powered by super high-flux membrane). The clearance became effective on July 28, 2026
- ELISIO-HX features NIPRO’s proprietary super high-flux membrane technology, designed to enhance the removal of larger middle-molecule uremic toxins while maintaining albumin retention. The dialyzer is compatible with existing hemodialysis systems and established clinical workflows
- Following the clearance, NIPRO plans to commercialize ELISIO-HX in the US. The dialyzer has previously been introduced in Japan, Europe, and Latin America and is intended for use in patients with end-stage kidney disease
Ref: NIPRO | Image: NIPRO | Press Release
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