AI-Enabled TruDi Navigation System Was Alleged to Have Contributed to Patient's Stroke During May 2023 Sinuplasty
Patient Donna Fernihough allegedly suffered carotid-artery damage and a same-day stroke during a May 19, 2023 balloon sinuplasty in Texas in which surgeon Marc Dean reportedly used Acclarent's AI-enabled TruDi Navigation System. Her lawsuit alleged the system's AI-assisted navigation contributed to unsafe guidance during the procedure; Acclarent and Integra LifeSciences, which later acquired Acclarent, denied evidence linking TruDi's AI to the injuries.
- Date it happened
- 2023-05-19
- Organisation involved
- Surgical teams using TruDi Navigation System, Marc Dean
- Product, system or model
- TruPath, Machine-learning surgical planning systems, Balloon sinuplasty navigation systems, AI-enabled surgical navigation systems, AI-enabled healthcare systems, Acclarent TruDi Navigation System
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