Smith+Nephew (SNN) said Wednesday it has obtained De Novo classification by the US Food and Drug Administration for its TESSA spatial surgery system.
The system uses computing and AI technology to support personalized planning, augmented reality, advanced imaging and other features to back arthroscopic procedures, the company said.
The system's first indication for use is femoral anterior cruciate ligament reconstruction surgery of the knee, according to the company.
The system will be launched in Q3 2026 and will see wider deployment next year, the company said.
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