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Hemodialysis urea clearance calculation software approved for marketing

CCFDIE| Updated: 2023-02-27

Recently, the innovative product Hemodialysis urea clearance calculation software of Beijing IfmSoft Co., Ltd is approved by China NMPA.

This is a domestic innovative product with independent intellectual property right, of which the performance is on par with advanced international standards. It is intended for the calculation of urea clearance in adult patients with maintenance hemodialysis, but not for the calculation of residual renal function.

Urea clearance is an important index to measure the adequacy of hemodialysis. At present, the calculation usually adopts the invasive blood collection method. It has some defects such as cumbersome operation and inability to keep continuously calculation, which may lead to anemia in patients. Compared with the blood collection method, the product can calculate the urea clearance rate by combining the existing indexes and hemodialysis treatment parameters of patients, and calculate the simulated body fluid volume of patients according to the local urea dynamics model. It has advantages such as non-invasive, simple operation, continuous calculation, and can adjust the dialysis plan in time, and effectively improve the dialysis effect of patients.

The NMPA will strengthen the post-marketing surveillance of the product to protect the safety of medical devices used by patients.