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Smith+Nephew’s TESSA Spatial Surgery System granted De Novo classification by the FDA sparking a generational leap in Sports Medicine for personalized planning and procedural innovation
Smith+Nephew announced that the U.S. Food and Drug Administration granted De Novo classification for its TESSA Spatial Surgery System. This regulatory approval marks the first device in a new FDA category for intra-articular orthopedic stereotaxic navigation instruments. The system utilizes AI, augmented reality, and real-time tracking to enhance arthroscopic procedures. It generates patient-specific 3D anatomical models from preoperative scans, overlaying them onto live 4K video to assist surgeons. The initial indication is for femoral tunnel placement during [...]