Comparative Effectiveness for AI MedTech
Nicole Coustier Published on: 04/09/2024
Why comparing your AI MedTech solution to the status quo isn’t enough for payer approval.
Evidence Planning
Nicole Coustier
The World After FDA Clearance: From HOORAY! To WAIT, WHAT?
Nicole Coustier Published on: 20/08/2024
FDA clearance is a milestone—not the finish line. Why reimbursement hurdles follow right after.
Commercialization PlanningFeatured
Wow. TCET Actually Happened.
Nicole Coustier Published on: 14/08/2024
A breakdown of the finalized TCET rule and what it means for Breakthrough Devices.
Coding and Payment Mechanics
AI MedTech Reimbursement: Insights from Recent Literature
Nicole Coustier Published on: 13/08/2024
A review of what peer-reviewed publications reveal about payer adoption of AI tools.
Payer Coverage
Relearning English When it Comes to FDA and CMS Jargon
Nicole Coustier Published on: 04/06/2024
MedTech teams often misunderstand what regulators mean. This article translates FDA and CMS jargon into actionable insights for reimbursement.
U.S. Healthcare FundamentalsFeatured