Acclarent's AI-Powered Surgery Tool Allegedly Injures Patients, Lawsuits Claim
Two patients allege that Acclarent's TruDi Navigation System, which uses AI to confirm device positioning during sinus surgery, misled surgeons and caused severe injuries including strokes. The FDA has received over 100 reports of malfunctions and at least ten injuries since AI was added. Lawsuits claim the company rushed the technology to market with only 80% accuracy, making the device less safe than before. Acclarent denies any causal connection, and the cases are ongoing.
- Date it happened
- 2022-01-01
- Organisation involved
- Acclarent
- Product, system or model
- TruDi Navigation System
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