Last week, the FDA unveiled a game-changing fast-track for AI diagnostics, but a hidden challenge is already causing chaos for unprepared companies. We break down the new 'Agile PMS' framework and what it means for your market access strategy.

This new rule isn't just theory. We explore the real-world case of CardiaAI, a leading Boston-based startup that had its breakthrough product put on hold. Their story reveals the critical resource and data management gaps that this new regulation exposes, serving as a warning for the entire industry.

This week's insights:

- What exactly is the FDA's 'Agile PMS' and is your current system compliant?

- Why did the new fast-track pathway immediately become a roadblock for a top startup?

- What are the three critical data infrastructure changes you need to make right now?

- How can you leverage existing technical dossiers for the new PMS requirements without starting from scratch?

- Is it possible to automate the new real-time reporting demands?

- What are the hidden costs associated with this new compliance framework?

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