Market Pathways covers the people, challenges, and opportunities impacting the global medtech regulatory, reimbursement, and policy communities. We invite you to explore our coverage. Think Strategically.
Subscribe Today
A sortable and searchable running inventory of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
In this week’s Pathways Picks: Breakthrough devices will lose streamlined path to add-on payments, and more Medicare updates; FDA details MDUFA VI user fee amounts; UK defines when an AI scribe is a medical device; registering trials in Canada; and more global medical policy updates.
The Medicare agency finalized plans to cancel its “alternative pathway” to new technology add-on and device pass-through payments for FDA Breakthrough Devices. However, it agreed to add a transitional period allowing firms to access the streamlined route for the next two years if they get a breakthrough designation by September.