FDA Clears Cloudcath Peritoneal Dialysis At-Home Patient Monitor

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CloudCath today announced that it received FDA 510(k) clearance for its CloudCath remote monitoring system for peritoneal dialysis patients.

San Francisco, California-based medical startup CloudCath designed the monitoring system as a data-driven, cloud-based, remote monitoring platform for at-home monitoring of peritoneal dialysis. It uses continuous analytics with its technology to integrate seamlessly into a patient’s daily PD protocol, according to the company.

“The opportunity to remotely and proactively manage our PD patients’ addresses a major obstacle to greater PD adoption. Today’s standard-of-care for patient monitoring is subjective. It relies on patients to self-monitor their dialysate fluid with either a decades-old ‘newspaper test,’ the ability to read text through fluid drainage lines, or waiting for signs of pain and discomfort in the abdomen,” Glenn Chertow, professor of medicine in nephrology at Stanford School of Medicine said in a news release. “With the CloudCath solution, automated fluid analytics and real-time notifications will enable us to monitor and follow up with patients quickly, so they can stay home and on PD until a successful transplant.”

CloudCath CEO and cofounder Aly ElBadry said CloudCath’s FDA clearance comes at a dynamic time in the dialysis market: “With the 2019 Executive Order calling for increased use of at-home dialysis, CloudCath’s automated sensing and advanced PD care algorithm build a stronger connection between clinicians and patients to help dialysis providers meet these goals.”