LiberDi Gets FDA Clearance for Its Digital Dialysis System

The device allows patients to perform dialysis at home or at the workplace, by themselves.

Liber Di Ida Device

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, by themselves, monitored by their physician using the advanced telemedicine capabilities of the system. 

One out of ten people in the world experience kidney disease. In advanced stages of the disease, dialysis is the most common treatment. Dialysis is a life-support treatment which extends average life expectancy by 5 – 10 years.  Approximately 90% of the patients spend half of their remaining lifetime dialyzing in clinics. liberDi's system is positioned to replace traditional full-service, in-clinic care with a self-care system suitable for many people on or requiring dialysis.

liberDi conducted two initial clinical studies to demonstrate the safety and effectiveness of the Portable Peritoneal Dialysis system on patients requiring dialysis. Forty two subjects used the system for dialysis under the supervision of three medical centers in Israel. The studies' results endorse that liberDi's Digital Dialysis Clinic is safe to use and feasible for an automatic PD exchange. liberDi also performed a human factor validation study evaluating all user groups: people requiring dialysis and their caregivers, as well as healthcare professionals such as nephrologists and dialysis nurses. The study simulated a real-world environment and proved that anyone can operate the system following a single 90 minute proper training session.  

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