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.
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In this week’s Pathway’s Picks: A first look at the EU’s long-awaited, comprehensive proposal to streamline the Medical Device and IVD Regulations; FDA loosens what real-world evidence is allowed in submissions; Market Pathways’ PCCP analysis; UK-Singapore pact; TAVR Medicare coverage reconsideration; and many more policy updates from Europe, the US, and Asia.
An infographic look at FDA's use of Predetermined Change Control Plans.
The two agencies are launching allied programs next year to jump-start market access for digital tools addressing chronic conditions. The nascent CMS ACCESS Model seeks to bypass Medicare barriers for digital health by offering outcome-aligned payments to technology-oriented clinics and companies. Meanwhile, FDA’s TEMPO pilot will grant regulatory enforcement discretion to some technologies used in the Medicare model. But implementation questions remain.