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In this week’s Pathways Picks: Sticking points and progress from FDA-industry MDUFA VI talks; FDA veteran Melissa Torres takes top regulatory spot at AdvaMed; FDA eyes 510(k) exemptions; China expands devices requiring national approval to start clinical trials; and more updates from the US, EU, and UK.
Breast cancer is highly manageable when caught early, yet clinicians still face challenges: patient stratification after screening isn’t precise enough, and surgical outcomes could be improved. We spoke with Clairity, Cairn Surgical, and Resilient Medical—innovators working to raise the standard of care for this disease that predominantly affects women.
South Korean regulators have released multiple policies impacting medtech products, including a new fast-track market pathway. Excerpted from Pathways’ Picks January 28: South Korea Fast Track, Minnesota Letter, PPE Supply Ideas, and More.