CloudCath receives FDA clearance for novel at-home monitoring system in peritoneal dialysis patients

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CloudCath at-home PD monitoring system

CloudCath announced today it has received US Food and Drug Administration (FDA) clearance for the CloudCath system—which the company claims is the world’s first data-driven, cloud-based, remote monitoring platform for peritoneal dialysis (PD) patients. The company is planning a limited launch of the CloudCath system “in the coming months”, with several clinics in targeted regions of the USA.

The CloudCath system delivers continuous analytics from the comfort of a patient’s home with state-of-the-art technology that integrates seamlessly into the patient’s daily PD protocol, a CloudCath press release states. It sends real-time notifications to both clinicians and patients to facilitate the patient monitoring of dialysate fluid required for the safe home use of PD.

“The opportunity to remotely and proactively manage our PD patients addresses a major obstacle to greater PD adoption,” said Glenn Chertow (Stanford University School of Medicine, Stanford, USA). “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. 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.”

Promising early data show patients and clinicians may be alerted to the need for evaluation days before the onset of symptoms, enabling patients to seek early medical intervention, diagnosis, and treatment, the release adds.

“FDA clearance of the CloudCath solution comes at a dynamic time in the dialysis market,” added Aly El Badry, CEO and co-founder of CloudCath. “With the 2019 Executive Order [part of the Advancing American Kidney Health initiative] 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. We are excited to deliver new health insights and care algorithms that aim to eventually reduce hospitalisations, and improve quality of life for PD patients.”

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