SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership

SEOUL, South Korea, May 29, 2026 /PRNewswire/ -- South Korea-based medtech innovator SKIA has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its augmented reality (AR) surgical guidance system, SKIA HEAD.

Unlike traditional navigation systems that require bulky, stationary equipment, SKIA HEAD is a tablet-based platform. The system converts preoperative medical imaging data into high-fidelity 3D anatomical reconstructions. These models are then projected directly onto the patient’s body in real time, allowing surgeons to see beyond the surface and into the patient’s internal anatomy.

A critical component of this portability and accuracy is the hardware integration: SKIA HEAD is powered by high-precision Structure Sensors. These medical-grade scanning sensors allow the system to map the patient’s physical environment and anatomy with extreme accuracy, ensuring the AR overlay remains perfectly aligned during the procedure.

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