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Fitting rapidly advancing AI and digital tools into established device regulatory frameworks is a challenge, but that hasn’t stopped policymakers on both sides of the Atlantic from recent efforts to redraw the lines. Experts discuss recent missteps, deregulation, experimentation, and the need for more resources and a new mindset.
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.
A MHRA proposal would allow firms to rely on EU MDR/IVDR CE marks indefinitely in Great Britain. Excerpted from Pathways’ Picks February 18: Britain Gives in to the CE Mark, CMS ACCESS Updates, South Korea Wellness Policy.