As AI enters the operating room, reports arise of botched surgeries and misidentified body parts (Reuters Special Report, 9 February 2026)

Summary

Medical device makers have been rushing to add AI to their products. While proponents say the new technology will revolutionize medicine, regulators are receiving a rising number of claims of patient injuries.

This Reuters Special Report investigates some of the hazards associated with AI-enabled medical devices, including errors in a navigation system integrated into a medical device used in ENT surgery, AI software used for prenatal ultrasound scans that misidentified fetal body parts and AI assisted heart monitors that failed to recognise abnormal rhythms. 

Issues with the capacity of the U.S. Food and Drug Administration (FDA) to review the flood of new AI-enabled medical devices are also raised, as well as concerns that the FDA's traditional approach to regulating medical devices may no longer be fit for purpose.