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Reuters reports that after AI features were added to Acclarent’s TruDi sinus-navigation system, FDA malfunction and adverse-event reports tied to the device rose from single digits pre-AI to at least 100 reports, including at least 10 reported injuries between late 2024 and November 2025. Reuters also describes alleged navigation failures in surgeries, including a reported skull-base puncture case, while noting litigation disputes over causation. The FDA’s own public list shows 1,300+ AI-enabled medical devices authorized for U.S. marketing, underscoring how fast deployment is scaling across specialties. The contradiction is now obvious: hospitals are getting AI at platform speed while post-market safety fights still run at analog pace.