Smith+Nephew's TESSA Spatial Surgery System wins FDA De Novo clearance

Product / TechRegulation
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Smith+Nephew has received De Novo classification from the U.S. Food and Drug Administration for its TESSA Spatial Surgery System, a first-of-its-kind device in a new FDA category for intra-articular orthopedic stereotaxic navigation instruments. The system uses preoperative MR or CT scans with cloud-based deep-learning algorithms on Amazon Web Services and NVIDIA AI infrastructure to generate patient-specific 3D anatomical models, overlaying them onto live 4K arthroscopic video for real-time navigation. Its first indication is femoral anterior cruciate ligament reconstruction surgery of the knee, where femoral malposition at 29% and tibial malposition at 11% are among the most common reasons for ACLR failure. The TESSA System will be commercially introduced during Q3 2026 with increased deployment in 2027. The technology was originally developed by Perceive3D S.A., a University of Coimbra spin-off acquired by Smith+Nephew.

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Smith+Nephew received FDA De Novo clearance for its TESSA Spatial Surgery System, a first-of-its-kind device.

Robotics & Physical AI · 1 stocks

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Perceive3DPrivate▲ Positive
Technologyrelevance

Perceive3D originally developed the technology behind the TESSA system, which was acquired by Smith+Nephew.

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