LiberDi’s Home Dialysis Device Cleared

Israel-based portable dialysis devicemaker liberDi has received FDA clearance for its Digital Dialysis Clinic, which allows patients to have dialysis at home while being monitored by a telemedicine provider.

The liberDi device can complete a treatment in about 20 minutes, is battery operated and weighs less than 3 kilograms (6.6 pounds).

Dialysis, which removes waste and fluid from the blood when the kidneys are failing, must be repeated three times a week and can take several hours in a clinical setting.

The Digital Analysis Clinic enables healthcare providers to access data from the treatments through a secure cloud-based portal.

The FDA clearance was supported by a study evaluating 42 patients from three medical centers in Israel that showed the device was safe and effective. The company also conducted a human factor validation study that showed users could operate the system after a 90-minute training session.