Despite concerns about regulatory turbulence, there are no signs of an FDA slowdown. 510(k) clearance volumes rose by 3.5% in H1 2026 compared with H1 2025, while review times remain at pre-pandemic levels.
The more striking trend is the type of products being approved. AI and software accounted for 13% of De Novo approvals across the full 2021–2025 period, but nearly half in 2026. Since De Novo approvals create new product categories that other companies can later enter through the 510(k) pathway, this points to broader adoption in the coming years.

Beyond product approvals, AI is also beginning to deliver measurable results in clinical practice. At Northwestern Medicine, reported results from the AI-powered documentation system DAX Copilot include 11.3 additional patient visits per physician per month, a 24% reduction in documentation time and an ROI of 112%.