SKIA HEAD AR Surgical Guidance System Gains FDA Clearance

May 29, 2026
South Korea-based SKIA has received FDA 510(k) clearance for its SKIA HEAD augmented reality surgical guidance system, paving the way for a U.S. launch through a partnership with Structure.

SKIA has received FDA 510(k) clearance for its augmented reality surgical guidance system, SKIA HEAD, announced in a press release. The clearance allows the company to begin commercial distribution of the system in the United States, supported by a hardware partnership with Structure.

SKIA HEAD is a tablet based platform that converts preoperative imaging data into three dimensional anatomical models. These models are projected onto the patient's body during surgery, allowing surgeons to visualize internal structures in real time. The system uses Structure Sensors to map the surgical environment and maintain precise alignment of the augmented overlay.

SKIA stated that the partnership with Structure will support its U.S. expansion by combining Structure's hardware with SKIA's software expertise. The company has previously deployed its SKIA Body solution in India and is conducting clinical trials for additional AR platforms, including SKIA Breast, in collaboration with major South Korean hospitals.

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