Smith+Nephew Gains FDA De Novo Status for AI-Based TESSA Surgical Navigation System
Smith+Nephew has secured U.S. Food and Drug Administration (FDA) De Novo authorisation for its TESSA Spatial Surgery System, an advanced digital solution designed to support surgeons in performing more precise arthroscopic procedures.
The AI-powered TESSA (Tracking Enabled Spatial Surgery Assistant) platform combines three-dimensional imaging, augmented reality, surgical navigation, and real-time tracking capabilities to provide enhanced procedural guidance.
By analysing patient-specific MRI and CT scan data, the system creates customised 3D anatomical models using cloud-based artificial intelligence technology.
During arthroscopic surgery, the platform projects the personalised anatomical model onto live 4K surgical video, enabling surgeons to better understand anatomy and improve accuracy during critical steps of the procedure.
The initial application of TESSA is focused on anterior cruciate ligament reconstruction (ACLR) of the knee, where precise tunnel positioning plays an important role in surgical success.
The FDA clearance places TESSA in a newly established device category for intra-articular orthopaedic stereotaxic navigation instruments, paving the way for future innovations in image-guided surgery.
The technology incorporates developments from Perceive3D S.A., a University of Coimbra spin-off acquired by Smith+Nephew.
The company plans to launch the TESSA Spatial Surgery System commercially in the third quarter of 2026, followed by broader adoption across sports medicine applications in 2027.
