liberDi receives FDA 510(k) for its digital dialysis clinic
Israeli company liberDi received FDA 510(k) clearance for its Intelligent Dialysis Assistant, accompanying IDA cartridge with a medical supervision portal, and IDA smartphone app.
IDA allows patients to undergo peritoneal dialysis outside of a clinic while being remotely monitored by a medical professional via the device’s telemedicine capabilities.
Peritoneal dialysis is one of the two methods of treating kidney failure and is typically performed at a dialysis center or in a hospital by trained healthcare professionals.
The IDA device permits automatic single or multiple exchanges of dialysate solution for adults with renal failure. It comes with a single-use cartridge that interfaces with the Twin Bag Set (should that be the patient’s dialysis prescription) and the patient’s peritoneal catheter.
The medical supervision portal is a physician-facing platform for healthcare professionals to oversee the patient’s dialysis treatment, and the IDA smartphone app allows patients to review their healthcare professional’s treatment recommendations.
“Receiving FDA clearance for our state-of-the-art Digital Dialysis Clinic technology is a huge achievement for liberDi. This is a big step forward in liberDi’s journey to improve the quality of life of people on dialysis.
“liberDi’s system is designed to provide these patients with ease of use, freedom of movement, automatic catheter connection flush technology and patient monitoring while performing their daily dialysis activities from the comfort of their home or workplace. liberDi frees people from spending half of their lives in dialysis centers, which is a disruptive technology in the dialysis market,” the company’s CEO Hezkiah Tsoory said in a statement.
THE LARGER TREND
Peritoneal dialysis patients can spend three to four hours on a machine each session three times a week, according to Mount Sinai. Home sessions are shorter, but patients need training for needle placement and blood pressure monitoring.
AWAK Technologies, a medical technology company, also provides a remote dialysis platform using regeneration technology for end-stage renal disease.
The Singapore-headquartered company received FDA Breakthrough Device Designation in 2019 for its AWAK Peritoneal Dialysis (AWAK PD) device, a wearable and portable system.