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Home » CloudCath Gets 510(k) Clearance for Its Peritoneal Dialysis Monitor
CloudCath Gets 510(k) Clearance for Its Peritoneal Dialysis Monitor
February 17, 2022
CloudCath has received the FDA’s 510(k) clearance for its CloudCath System, a remote monitoring platform for peritoneal dialysis patients with end-stage renal disease.
The system delivers continuous analytics in the patient's home that is integrated into the patient's daily dialysis protocol. It also sends real-time notifications to clinicians and patients to help monitor dialysate fluid, which is required for safe home use of peritoneal dialysis.
The San Francisco, Calif.-based company said it plans a limited launch of the system in the coming months in targeted regions of the U.S.
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