CloudCath Gets 510(k) Clearance for Its Peritoneal Dialysis Monitor

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.