TruDi


"Acclarent said the software for its TruDi Navigation System would now use a machine-learning algorithm to assist ear, nose and throat specialists in surgeries.

"The device had already been on the market for about three years. Until then, the U.S. Food and Drug Administration had received unconfirmed reports of seven instances in which the device malfunctioned and another report of a patient injury. 

"Since AI was added to the device, the FDA has received unconfirmed reports of at least 100 malfunctions and adverse events.

"At least 10 people were injured between late 2021 and November 2025, according to the reports. Most allegedly involved errors in which the TruDi Navigation System misinformed surgeons about the location of their instruments while they were using them inside patients’ heads during operations."


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