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In this week’s Pathways Picks: Switzerland and EU make progress on mutual recognition; notified bodies lodge formal concerns with MDR/IVDR proposals; South Korea will allow predetermined change control; Brazil launches UDI database; global harmonization updates the week before IMDRF meets in Singapore; CMS targets equipment fraud; and HHS cancels Claude AI.
Years of macro and policy headwinds have dragged down medtech valuations, but the industry may be entering a period where fundamentals and innovation reignite investor sentiment. Strategics and private equity alike are repositioning their portfolios around new, higher‑growth opportunities. The AAOS meeting in New Orleans will offer a look at how aggressively the sector is preparing for its next growth leg. Watch our interview with Ryan Zimmerman of BTIG and Masha Dumanis of Kx Advisors.
Rick Abramson picked to lead FDA’s Digital Health Center of Excellence. Excerpted from Pathways’ Picks Febraury 25: Tariff Topsy-Turvy, CPT Panel Decisions, Reliance in South Africa.