Bengaluru: Medtronic said on Friday the U.S. Food and Drug Administration has cleared its surgical system for cranial and ear, nose and throat procedures, expanding the platform beyond the spine indication it received earlier this year.
The medical device maker’s system, called Stealth AXiS, combines surgical navigation, imaging and robotics to guide surgeons during complex procedures.
For cranial procedures, the system uses artificial intelligence to automatically generate brain maps and display key neural pathways to help guide surgical planning and execution.
For ENT surgeries, it provides precise navigation and clearer views of the sinuses and skull base.
Stealth AXiS was first cleared by the FDA in February for use in spine surgery, where it introduced real-time tracking tools that allow surgeons to see spinal motion and alignment without repeated imaging, according to the company.
“This system is designed to help surgeons move with greater clarity, confidence, and control in the operating room, while creating a powerful platform for the next generation of ENT innovation,” said Sean Haag, President of the Ear, Nose and Throat business at Medtronic.
The company on Tuesday cut its fiscal 2026 profit forecast to $5.50 to $5.54, citing a one-time charge of about $157 million tied to payments related to a research collaboration and the U.S. initial public offering of its diabetes unit, MiniMed.
This month, the U.S. FDA also cleared the company’s insulin pump, branded as MiniMed Flex – a decision that came several months earlier than anticipated.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shreya Biswas)
