FDA Clears Continuous Renal Replacement Therapy Device for Babies

The FDA granted marketing authorization for Medtronic’s Carpediem continuous-hemodialysis system for babies.

The device is the first cleared for continuous renal replacement therapy in patients weighing between 5.5 and 22 pounds with acute kidney failure or fluid overload.

The FDA reviewed the device through the De Novo premarket review pathway for low- to moderate-risk devices of a new type.