The U.S. Food and Drug Administration switched on its agency-wide generative AI system Elsa on June 2, 2025. The promise was faster scientific reviews, less bureaucratic “busywork,” and ultimately quicker access to new therapies. It’s only been six months, and the system is not without its flaws, but it’s definitely marked the start of a new AI era in how food, drugs, and devices are regulated. What effects of deployment can we see so far?

As the year draws to a close, major analytics firms traditionally share their view on where the medtech industry is heading and what to expect in the near future. We have gone through these reports and distilled the essentials: from the explosive growth of AI in medical devices and the portable tech market to regional regulatory specifics and shifting investment priorities. This article brings together the key figures, insights, and directions that will shape medtech over the coming years.