Regulatory & Reimbursement
FDA Output, March 2025
Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in March 2025. Updated March 25, 2025.
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Business Strategies
The Next Frontier: Transforming Medical Device Commercialization
To thrive in today’s evolving healthcare market landscape, medical device companies must take a cohesive, strategic approach to address the complexities and opportunities of the current environment. Success will hinge on aligning commercial models with customer priorities, reducing inefficiencies, and leveraging technology to drive smarter decisions. By Jeremy Cohen, Spinnaker Life Sciences Strategy Consulting.
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Pathways’ Pick of the Week
Pathways' Pick of the Week: Industry Spotlights MDR/IVDR Burdens
MedTech Europe’s new report on the administrative burden of MDR and IVD regulations. Excerpted from Pathways’ Picks March 19: Dr. Oz Hearing, FDA Office Challenges, China Picks, and More.