Smith+Nephew has received FDA de novo classification for its TESSA spatial surgery system, an AI-enabled navigation platform designed to assist surgeons during arthroscopic procedures.
The system combines preoperative MRI or CT imaging with cloud-based AI to create patient-specific 3D anatomical models that are overlaid onto live arthroscopic video, providing real-time navigation during surgery. The first FDA-cleared indication is for femoral anterior cruciate ligament reconstruction, where the technology is intended to assist surgeons with femoral tunnel placement, according to a July 29 news release.
The de novo classification establishes a new FDA device category for intra-articular orthopedic stereotaxic navigation instruments. The company plans to begin a limited commercial launch of the TESSA system in the third quarter of 2026, with broader deployment expected in 2027.
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