iRen Medical News
3 articles
growth-positive
Israeli dialysis system scores FDA approval, moves treatment home
Israeli company liberDi has received FDA approval for its Digital Dialysis Clinic, allowing patients to perform dialysis at home while being monitored by their physician using advanced telemedicine. The system includes automatic catheter flush technology and sensors to collect vital signs. It is portable, lightweight, and has cellular connectivity. The approval is expected to improve the quality of life for patients and disrupt the dialysis market. Home dialysis is still relatively uncommon, but doctors prefer it over hospital treatment. liberDis system differentiates itself with its portability and infection protection. More trials and manufacturing scale-up are needed. The company aims to free patients from spending half their lives in dialysis centers.
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liberDi receives FDA regulatory clearance for its digital dialysis system - The Trendlines Group
liberDi has received regulatory clearance from the FDA for its Digital Dialysis Clinic, which allows patients to perform dialysis at home or at the workplace. The system is positioned to replace traditional in-clinic care with a self-care system. The company conducted clinical studies to demonstrate the safety and effectiveness of the system. The FDA clearance is seen as a huge achievement for liberDi and a big step forward in improving the quality of life for dialysis patients. The CEO and Chairman of liberDi expressed excitement about bringing the technology to the US market. The development is praised by a professor in renal medicine as making at-home peritoneal dialysis easier and more accessible globally.
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liberDi readies first-in-man study of portable dialysis system - BioTuesdays
Closely-held liberDi plans to initiate in the first half of 2018 the first-in-man clinical trial of its Smart Peritoneal Dialysis System, a small, portable and automatic dialysis device, which is designed to improve patient’s quality of life, and reduce treatment costs and complications. The low utilization of home dialysis is a lost opportunity to improve patient’s quality of life and decrease healthcare costs. Only 11% of patients worldwide receive peritoneal dialysis at home because existing devices have significant limitations for patients and physicians, as well as a risk of peritonitis. liberDis system aims to address these limitations and make home dialysis more accessible. The company completed design and initial testing of a second prototype device in 2017 and plans to begin clinical testing in the first half of 2018.
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