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.
FundamentalsFeatured
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.
Payer CoverageEvidence Planning
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.
Evidence PlanningCommercializationFundamentals
