The FDA has granted Breakthrough Device Designation for US-based medical technology company CardioRenal for their RenalGuard Therapy device, used to treat a kind of kidney disease.
RenalGuard Therapy is used to prevent acute kidney injury (AKI) in patients who are at risk of developing cardiac surgery associated AKI (CSA-AKI). It works by maximising urine output while balancing hydration, utilising real-time urine output monitoring and IV infusion using a re-hydration system.