RenalGuard Therapy Gets Breakthrough Device Designation for Prevention of Cardiac Surgery Associated AKI
The FDA granted Breakthrough Device Designation for CardioRenal Systems' RenalGuard Therapy device for the prevention of acute kidney injury.
The FDA granted Breakthrough Device Designation for CardioRenal Systems' RenalGuard Therapy device for the prevention of acute kidney injury.
As finalized, the rule will reduce the lag between FDA marketing authorization and subsequent Medicare coverage for innovative medical devices.
The FDA granted Breakthrough Device Designation for CardioRenal Systems' RenalGuard Therapy device for the prevention of acute kidney injury.