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RenalSense Obtains CE Mark for its Clarity RMS(TM) Critical Care System for Real-time Monitoring of Urine Flow
JERUSALEM, Aug. 5, 2019 /PRNewswire/ -- RenalSense announced that it has obtained CE Mark approval for its Clarity RMS™ system for real-time monitoring of urine flow in the critical care and peri-operative setting. The CE Mark approval allows RenalSense to commercialize its technology in the European Union (EU), where Fresenius Medical Care (Bad Homburg) is its distribution partner.
AKI occurs in over 55% of ICU patients, and is often associated with a high risk of chronic kidney disease, as well as increased morbidity and mortality. Clarity RMS, which facilitates early detection of changes in renal function and Acute Kidney Injury (AKI) risk, is installed in leading medical centers in the United States and Israel. The system continuously measures urine flow and automatically transmits real-time data, as well as notifications of fluctuations, on a 24/7 basis to enable rapid intervention, monitoring of treatment efficacy and fluid management.
"The CE Mark is a significant milestone for RenalSense, enabling our distribution partner, Fresenius Medical Care, to launch sales to European medical centers, 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," said Avi Kleiman, CEO.
In addition to obtaining the CE Mark approval, RenalSense also received ISO:13485:2016 certification for its quality management system.
RenalSense is a privately owned medical device company dedicated to real-time renal diagnostics. The company's first product, Clarity RMS™, provides continuous, automatic monitoring of urine flow, enabling better patient care and ICU economics. RenalSense's next generation products will provide additional real-time parameters and expanded diagnostic capabilities, to further improve critical care management in the ICU and peri-operative setting.