Renal Care Devices
Devices for hemodialysis, peritoneal dialysis, and continuous renal replacement therapy in ESRD and AKI patients.
Definition
The renal-care segment includes in-center hemodialysis machines, home hemodialysis systems (NxStage), peritoneal dialysis cyclers, continuous renal replacement therapy (CRRT) for ICU AKI, dialyzers, and vascular access devices. The segment is reimbursement-dominated: ESRD care is one of the few diagnoses with universal Medicare entitlement under the End-Stage Renal Disease Program (1972 Social Security Amendments).What this means in practice
The 2019 'Advancing American Kidney Health' executive order pushed home dialysis adoption and the development of wearable/implantable kidney devices via the KidneyX innovation prize.- •Designing without regard to the bundled ESRD PPS payment structure.
- •Underestimating dialysis-water purity requirements (AAMI/ANSI/ISO 13959).
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
FDA's most stringent device marketing application, required for high-risk Class III devices.
Payment tied to outcomes and total cost of care, not volume of services.
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Primary references
3 sources- 1
CMS ESRD Conditions for CoverageVerifiedCMScms.gov
- 2
KidneyXVerifiedHHS / ASNkidneyx.org
- 3
MedTech Europe - Facts & FiguresVerifiedMedTech Europemedtecheurope.org
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