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Home Dialysis

FDA clears Baxter’s virtually connected, in-home peritoneal dialysis system

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FDA clears Baxter’s virtually connected, in-home peritoneal dialysis system
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By writer to www.fiercebiotech.com

Baxter has acquired clearance from the FDA for the newest model of its automated peritoneal dialysis system designed for residence use, combining it with a digital platform that goals to assist sufferers with kidney illness handle their care remotely.

The Homechoice Claria system was cleared for each adults and kids. Its interface is offered in 38 languages and options step-by-step, voice-activated directions via an accompanying app to assist information the person via remedy.

In the meantime, Baxter’s two-way Sharesource platform—already used with greater than 6 million residence dialysis therapies within the U.S. and over 20 million peritoneal therapies globally—supplies knowledge to clinicians and notifies them if points happen throughout remedy, together with if the affected person goes off their remedy schedule.

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Sharesource additionally connects to Baxter’s touchscreen-enabled fashions, marketed because the Amia automated peritoneal dialysis system within the U.S. and Canada, and because the Kaguya system in Japan.

“Our purpose stays to increase accessibility to home-based remedy for U.S. sufferers with kidney failure,” said Gavin Campbell, common supervisor of Baxter’s U.S. renal care enterprise, which goals to make the system accessible within the coming weeks.

RELATED: Baxter nets FDA de novo clearance for a new class of dialysis filter, closer to the human kidney

“Homechoice Claria with Sharesource will assist accelerated residence dialysis development by bringing the advantages of a two-way linked automated peritoneal dialysis system mixed with a easy, intuitive system to extra sufferers within the U.S.,” Campbell added.

The system follows a number of digital initiatives from Baxter aimed toward enhancing renal care, together with final 12 months’s debut of its free smartphone app that gives personalized data on power kidney illness, CKD&Me. The corporate additionally launched a digital peritoneal dialysis academy this previous August for U.S. nurses.

In the meantime, in hemodialysis, Baxter acquired a de novo clearance from the FDA for a brand new class of blood filter, the Theranova cartridge, which sifts out a wider vary of molecules to extra intently resemble the work carried out by the human kidneys.

— to www.fiercebiotech.com

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