RenalSense has started commercial sales of its Clarity RMSTM system in Europe in conjunction with its distribution partner Fresenius Medical Care (Bad Homburg). The Clarity RMS received CE Mark approval in August 2019.
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 already commercialized in the United States and installed in leading medical centers. 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 launch of our products to key medical centers in Europe is a significant milestone for RenalSense. Fresenius Medical Care is one of the largest medical technology companies in the world, and the undisputed leader in solutions for kidney injury. Fresenius’s strong presence and wide customer base throughout Europe provides us with a sound basis for delivering Clarity RMS to hundreds of medical centers. Our common goal is for real-time urine output to be monitored electronically, 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.