Renal trauma with laceration of the lower pole and subcapsular fluid collection below the kidney. Credit: Kristoffer Lindskov Hansen, Michael Bachmann Nielsen and Caroline Ewertsen.

RenalSense has obtained CE Mark approval for its Clarity RMS critical care system for real-time monitoring of urine flow in the critical care and peri-operative setting.

Following the approval, RenalSense will commercialise its Clarity RMS technology in the European Union (EU). Fresenius Medical Care (Bad Homburg) is serving as the company’s distribution partner in this region.

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Acute Kidney Injury (AKI), which occurs in more than 55% of ICU patients, is often associated with a high risk of chronic kidney disease and increased morbidity and mortality.

Clarity RMS facilitates the detection of changes in renal function and AKI risk in advance.

RenalSense noted that leading medical centres in the US and Israel are already using the technology.

By continuously measuring urine flow, Clarity RMS can automatically transmit real-time data. It also provides notifications of fluctuations on a regular basis for rapid intervention, monitoring of treatment efficacy, and fluid management.

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RenalSense CEO Avi Kleiman said: “The CE Mark is a significant milestone for RenalSense, enabling our distribution partner, Fresenius Medical Care, to launch sales to European medical centres, where urine output will now be able to be monitored electronically in real-time, as is the standard practice for other vital signs in the OR and ICU.”

The company has received ISO:13485:2016 certification for its quality management system, in addition to obtaining the CE Mark approval for Clarity RMS technology.

The company’s next generation products will provide additional real-time parameters and expanded diagnostic capabilities, bringing out improvements in critical care management in the ICU and peri-operative setting.