Relearning English When it Comes to FDA and CMS Jargon
Published on: 04/06/2024
MedTech teams often misunderstand what regulators mean. This article translates FDA and CMS jargon into actionable insights for reimbursement.
FDACMSFood and Drug AdministrationMedicareMedicaidAIExperimentalInvestigational
What Do Payers Mean by “Clinical Utility”?
Published on: 01/06/2024
“Clinical utility” is one of the most misunderstood payer terms. This article explains what U.S. payers expect and how to prepare.
AIArtificial IntelligenceMachine LanguageMLClinical UtilityEvidenceAI/MLInterventionPayersRegulatory ApprovalFDAFood and Drug Administration
FDA vs. CMS Mandates for Evaluating Novel MedTech
Published on: 31/05/2024
FDA approval ensures safety and effectiveness—but CMS needs proof of clinical value. Here’s how to align your strategy with both mandates.
NovelFDACMSFood and Drug AdministrationCenters for Medicare & Medicaid ServicesTechnical OerformanceSafety ProfileBiocompatibilityClinical ValueEfficiencyFDA ClearanceEvidenceReimbursementClinical Benefit
