New FREE course! DiMe is excited to share Google's Generative AI for Healthcare course with our community. Take this brief survey and begin the course specifically designed for medical professionals, administrators, and researchers who want to leverage AI in healthcare settings!
Your work in Stage C should allow you to answer the following questions:
Regulatory strategy
Have you obtained the necessary regulatory authorization for market entry?
Is a post-market compliance plan in place to meet evolving regulatory requirements?
Reimbursement pathways
Have viable reimbursement models and payment pathways been identified for the DHT?
Is sufficient real-world evidence available to support additional reimbursement decisions?
Business priorities
Is the go-to-market strategy optimized for maximum adoption and market penetration?
Have strategic partnerships been established to accelerate commercialization?
Is the business model structured for long-term sustainability and scalability?
Case studies
Learn how Caption Health successfully navigated Stage C by securing NTAP designation from CMS, developing a structured reimbursement strategy and expanded commercial adoption.
Learn how AppliedVR successfully obtained FDA market authorization for RelieVRx® via the De Novo regulatory pathway, facilitating future marketing and distribution in the US.