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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

Regulatory & Reimbursement

Device Firms Fight CMS’ Abrupt Reversal on Easier Access to Add-On Payments

Companies were caught off guard by CMS’ recent proposal to end a simplified path to add-on payments for FDA Breakthrough Devices. Industry is urging the agency to rethink its plan or at least slow it down to avoid undercutting firms that pursued clinical development for breakthrough-designated devices based on the current policy.

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Latest from MedTech Strategist

Actionable intelligence exploring the people, challenges, and opportunities impacting the global medtech community.

Start-Ups

The Digest June 2026

In this month's news, FDA clearances for several imaging technologies, Resmed expands into sleep medicine by buying Noctrix Health, TAP pilot progress, and more.

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Latest from Community Blog

MedTech Strategist's free Community Blog explores the passion behind the people, technologies, and companies impacting the global device space.

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