Tablo is Almost Home
Outset Medical released a study that the Tablo met both safety and efficacy endpoints for home. Currently FDA-cleared for use in hospitals and clinics, the new system is under evaluation by FDA for home dialysis use.
Fast Track AWAK
Based on successful human trials in Japan, a WAK wearable PD system using sorbent technology received FDA fast track status this year. With thrice-daily use, the device removed toxins and had no serious adverse events. And, since dialysate is regenerated, dramatically less fluid volume can be used.
No Stick Access!
Full-time access use is a sticking point (pun intended) for an artificial kidney. “Veins don’t like having plastic tubes in them,” noted Steven Ash, MD, FACP in a talk. CEO of HemoCleans Technologies LLC and Ash Access Technologies, Dr. Ash has worked on a needle-free access port for nearly 40 years. The STARgraft AV hemodialysis access graft, which causes less trauma than a catheter, has been in clinical trials since April.
When Pigs Fly—or are Transplanted
Since 2004, a Korean research center has been developing gnotobiotic miniature pigs and clinical platforms for xenotransplantation of pancreatic islets and cornea into humans. The group plans to use gene-editing to remove swine viruses, and anticipates starting human trials late this year.
VA and Google Deepmind Collaborate on AI to Detect AKI
Early treatment of acute kidney injury can be more successful and save kidneys. Using VA data, researchers at Google Deepmind developed an artificial intelligence model to detect AKI up to 48 hours before it would otherwise be identified.
Animal Testing Set to Begin for UCLA-U of A Implantable Artificial Kidney
Researchers on the UCLA-University of Arkansas team plan to test a new, filtration and electron deionization-based implantable kidney on pigs. Now suitcase-sized, the aim is to shrink the device to fit into a backpack.
Quanta Takes a Step Toward FDA Approval for the SC+ Home HD Machine
In a press release issued last week, Quanta—which recently raised $48M in a funding round—announced a partnership with Design Science to begin human factors testing of the SC+ with a diverse range of adult dialyzors in preparation for an FDA 510(k) application later this year.
Portable Nuclear Magnetic Resonance Scanner Could “See” Body Water
Removing enough—but not too much—water is key to the success of dialysis. A new way to measure fluid buildup under development by MIT researchers could make dialysis safer.
New AAKHI to Create Incentives for Innovations—Like Artificial Kidneys!
Growing a New Human Kidney
A free downloadable journal article describes three reasons to generate new human kidneys and reveals progress in efforts to do so.