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Global Medical Device Regulatory, Reimbursement, and Policy Review


Regulatory & Reimbursement

Pathways Picks September 20: A Busy Week in Medtech Policymaking

In a particularly active week of medtech policy updates: The UK launches an accelerated market access pilot pathway; MDR reform efforts pick up; CMS talks coverage reforms on Capitol Hill; FDA is in overdrive, with a barrage of guidance documents and reports on clinical trials, Breakthrough Devices, global harmonization, and more. Plus, updates on eSTAR, EUDAMED, digital health, and artificial wombs.

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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

Regulatory & Reimbursement

CMS Plans to Revise National Coverage Prioritization Process, and More From House Hearing

A Medicare official said on Capitol Hill today that CMS will propose revisions to its national coverage determination process next year to improve clarity around decisions about which technologies should be considered for coverage. Meanwhile, the agency is hoping to finalize its Transitional Coverage for Emerging Technologies (TCET) plan this year, while lawmakers try to press ahead with MCIT replacement legislation.

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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review


Regulatory & Reimbursement

Pathways Picks September 20: A Busy Week in Medtech Policymaking

In a particularly active week of medtech policy updates: The UK launches an accelerated market access pilot pathway; MDR reform efforts pick up; CMS talks coverage reforms on Capitol Hill; FDA is in overdrive, with a barrage of guidance documents and reports on clinical trials, Breakthrough Devices, global harmonization, and more. Plus, updates on eSTAR, EUDAMED, digital health, and artificial wombs.

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