What happened
Acclarent, a former Johnson & Johnson unit now owned by Integra LifeSciences, integrated artificial intelligence into its TruDi Navigation System in 2021. Post-AI enhancement, the US Food and Drug Administration (FDA) received unconfirmed reports of at least 100 malfunctions and adverse events, with 10 alleged patient injuries between late 2021 and November 2025. This compares to seven malfunction reports and one injury report before the AI update. Incidents included the system misinforming surgeons about instrument placement during chronic sinusitis procedures, leading to cerebrospinal fluid leaks, skull punctures, and allegedly injured major arteries.
Why it matters
AI integration into safety-critical systems increases liability and regulatory exposure for technology providers. The TruDi system's post-AI increase to over 100 unconfirmed malfunctions and 10 alleged injuries demonstrates the cost of failure. For founders and investors in AI-driven medical technology, this means more scrutiny from regulators like the FDA, which now authorises 1,357 AI devices, double the 2022 count, but struggles with oversight. CTOs and architects must anticipate higher validation costs and longer timelines for deploying AI in regulated environments, affecting market entry and product roadmaps.
Subscribe for Weekly Updates
Stay ahead with our weekly AI and tech briefings, delivered every Tuesday.
