When Silence is Golden in MedTech Reimbursement

Published on: 30/10/2024

In MedTech reimbursement, no news can be good news. Learn how to reduce payer confusion and build clarity into your strategy.

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When Silence is Golden in MedTech Reimbursement

The World After FDA Clearance: From HOORAY! To WAIT, WHAT?

Published on: 20/08/2024

FDA clearance is a milestone—not the finish line. Why reimbursement hurdles follow right after.

FDAPayer ExpectationsMedicarePayment ReadinessCommercial
The World After FDA Clearance: From HOORAY! To WAIT, WHAT?

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
Relearning English When it Comes to FDA and CMS Jargon

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
What Do Payers Mean by “Clinical Utility”?