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In this week’s Pathways Picks: A proposal would allow firms to rely on EU MDR/IVDR CE marks indefinitely in Great Britain; notified bodies’ guide on IVD-instrument pairs; a EUDAMED snapshot; CMS announces insurer agreements and pay rates for its ACCESS digital health model; South Korea updates wellness product v. medical device policies; and more.
The diagnostic industry, a perpetual valuation laggard to higher-profile subsectors of the life sciences, with a short-lived exception during the height of COVID-19, may finally be having a moment. Reflecting this optimism, industry experts on a recent Arizona State University online seminar highlighted the success of rising young and increasingly profitable tech-enabled diagnostics companies, labeling them the “Terrific 10,” a moniker that references the tech industry’s “Magnificent 7.”
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.