Insights
Medtech, measured
AI device authorizations: what the FDA record shows
2026-07-26FDA authorizations for AI-enabled imaging software grew twentyfold from 2018 to 2025 — then flattened in 2026. Every count queried from openFDA, query…
What a 510(k) clearance does not guarantee a buyer
2026-07-26A 510(k) clearance makes an AI device legal to sell — not clinically superior or commercially proven. The four gaps category buyers have to close themselves.
FDA cleared vs approved vs granted vs registered
2026-07-26Cleared, approved, granted, and registered mean very different things at the FDA. What each proves about an AI tool, and how to verify any claim yourself.
Introducing Insights
2026-07-25Welcome to Insights, the new analysis section of Elephant Hawk. Each week we publish a short, data-driven read on the medtech regulatory landscape — built…