Pure Global: US MedTech's Secret Path from FDA Nod to Sales

About this episode

This episode discusses a new FDA and CMS program that improves the transition from regulatory approval to Medicare reimbursement for innovative medical technologies.

In this episode, we dissect the groundbreaking new program from the FDA and CMS that bridges the gap between regulatory approval and Medicare reimbursement in the United. States. This policy shift is set to eliminate the "reimbursement valley of death" for the most innovative medical technologies. Imagine your breakthrough AI diagnostic for Alzheimer's just won FDA approval. The celebration is short-lived. Why? Because until last week, you faced a 'reimbursement desert,' potentially waiting years for Medicare to decide to pay for it, stalling your launch. A new joint FDA-CMS program just changed the entire game. We explore how. Key Questions Answered: - What exactly is the MedTech "reimbursement valley of death"? - How does the new TCET pathway grant immediate Medicare coverage? - Why has FDA approval traditionally been only half the battle in the US? - What kind of real-world evidence will CMS now require for permanent coverage? - How does this new rule change the investment landscape for AI and breakthrough devices? - Does temporary coverage guarantee a path to full reimbursement? - What new post-market surveillance strategies are now essential for success? - How can companies…

People in this episode

Host: Ran Chen

Topics covered

• MedTech
• FDA approval
• Medicare reimbursement
• regulatory strategy
• AI in healthcare
• post-market surveillance

Keywords

• reimbursement valley of death
• TCET pathway
• Medicare coverage
• investment landscape
• breakthrough devices
• post-market strategies

Mentioned in this episode

Organizations: FDA, CMS, Pure Global

Products: AI diagnostic for Alzheimer's

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