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Latest from Market Pathways

Global Medical Device Regulatory, Reimbursement, and Policy Review

Pathways' Document Depot

Docs of the Month: An EU Fast Track for Orphan Devices?

The EU Medical Device Regulation doesn’t contain any special provisions for devices addressing rare diseases or subpopulations, but policymakers worked with what they have last month in a guidance document laying out an approach to allow reduced clinical requirements for orphan devices. Here’s a look at the plan and some comparisons to US humanitarian device exemptions.

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Latest from MedTech Strategist

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

Business Strategies

Report from DDW 2024: Endobariatric Devices Create Enduring Effects

At the recent Digestive Disease Week, GI endoscopists paraded data showing that interventional weight loss procedures are still more cost-effective by a wide margin than semaglutide and with more durable effects. The meeting also highlighted duodenal mucosal resurfacing, a new type of metabolic surgery with the potential to put type 2 diabetes into remission.

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

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