Can an Artificial Kidney Finally Free Patients from Dialysis?
WEBAug 29, 2023 · Scientists at UC San Francisco are working on a new approach to treating kidney failure that could one day free people from needing dialysis or having to take harsh drugs to suppress their immune system after a transplant.
Breakthrough Devices Program | FDA
WEBThe Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of...
Medtronic launches new frontier to treat high blood pressure
WEBNov 17, 2023 · The U.S. Food and Drug Administration (FDA) today approved the Medtronic Symplicity Spyral™ renal denervation system for use in the United States. The system, which carries the FDA’s Breakthrough Device designation, uses radio frequency to disrupt overactive nerves in the kidneys and help lower blood pressure.
AWAK Technologies Announces FDA Breakthrough Device …
WEBNov 27, 2023 · The KDPP model helps to assess the risk of kidney disease progression and initiation of renal replacement therapy (dialysis or transplant), within a period of 1 year, 2 years and 5 years.
The Kidney Project successfully tests a prototype bioartificial kidney ...
WEBSep 9, 2021 · In the last few years, The Kidney Project successfully tested the hemofilter, which removes waste products and toxins from blood, and the bioreactor, which replicates other kidney functions, like the balance of electrolytes in blood, in separate experiments.
FDA grants breakthrough designation to Roivios' renal assist device
WEBApr 29, 2024 · Roivios has secured the US Food and Drug Administration’s (FDA) breakthrough device designation for its JuxtaFlow renal assist device (RAD), designed to provide kidney protection for patients undergoing cardiac surgeries.
FDA Grants Breakthrough Device Designation to KidneyIntelX™
WEBMay 2, 2019 · Renalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announces that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), …
CardioRenal Systems secures FDA Breakthrough Device …
WEBJan 23, 2023 · CardioRenal Systems has received the US Food and Drug Administration (FDA) Breakthrough Device Designation for its RenalGuard Therapy device to treat a type of kidney disease.
RenalGuard Therapy® Receives FDA Breakthrough Device …
WEBMILFORD, Mass., Jan. 20, 2023 /PRNewswire/ -- CardioRenal Systems, Inc. announced today that the FDA granted Breakthrough Device Designation for its RenalGuard Therapy ® device for the...
FDA grants Breakthrough Device designation to KidneyIntelX™
WEBMay 2, 2019 · Renalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announces that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for …