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In this month’s column, we spotlight the three most important streams of medtech policymaking activity in February: FDA’s launch of the Quality Management System Regulation, significant “regulatory reliance” moves internationally, and digital health delineations in Australia and South Korea.
One of The Foundry’s latest alumni offers a new twist on releasing trapped air for emphysema patients.
FDA’s device center touts its accomplishments in advancing global harmonization in FY 2025. Exerpted from Pathways’ Picks February 4: FDA Adopts QMSR, EU Harmonizes Standards, South Korea Spotlights Innovation.