NIPRO CORPORATION has received 510(k) clearance from the US Food and Drug Administration (FDA) for its ELISIO-HX dialyser, enabling the introduction of its HDs (haemodialysis powered by super high-flux membrane) approach in the United States.

The FDA clearance, effective from 28 July 2026, allows NIPRO to begin commercialising ELISIO-HX in the US. The company said the technology is designed to enhance haemodialysis treatment while using existing dialysis infrastructure and established clinical workflows.

ELISIO-HX features NIPRO’s proprietary super high-flux membrane technology, which is designed to improve the removal of larger middle-molecule uraemic toxins while maintaining albumin retention. The approach aims to enhance dialysis treatment without requiring new equipment or significant changes to current haemodialysis procedures.

The dialyser is intended for broad patient use and is compatible with conventional haemodialysis systems, allowing healthcare providers to integrate the technology into routine clinical practice using existing dialysis machines.

The launch in the United States follows the use of ELISIO-HX in Japan, Europe and Latin America, where the technology has been introduced across a range of healthcare settings.

Following the FDA clearance, NIPRO will begin the immediate commercial rollout of ELISIO-HX in the United States and will work with healthcare providers to support the adoption of its HDs approach in routine dialysis care.

 

Source: prnasia.com

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