Pure Global: US Digital Health's TEMPO Pivot - Opportunity or Trap?

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Pure Global: US Digital Health's TEMPO Pivot - Opportunity or Trap?

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The U.S. FDA just launched the TEMPO pilot program, a groundbreaking "regulatory-light" pathway for digital health devices. This episode of MedTech Global Insights unpacks what this major shift means for manufacturers, how it ties regulatory approval directly to reimbursement, and why the game is changing for chronic disease management technologies. We look at the case of Ceribell, a company that recently secured three FDA approvals in rapid succession. Their platform-based approach is a masterclass in leveraging these new, agile regulatory frameworks. Learn how their strategy of iterative, multi-indication approvals could become the new standard for success in the competitive digital health space. Key Questions Answered: - What is the FDA's new TEMPO pilot program and who is it for? - How does a "regulatory-light" approach change the requirements for market approval? - Why is a platform-based technology strategy now more critical than ever? - What are the hidden data and cybersecurity challenges within the TEMPO program? - How does this new U.S. policy impact global regulatory strategy for digital health? - What can we learn from Ceribell’s recent string of FDA successes? - How will the TEMPO pilot affect reimbursement pathways for new technologies? Contact us at info@pureglobal.com, visit https://pureglobal.com/, or access free AI tools and a medical device database at https://pureglobal.ai/.

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