South Korea-based medtech innovator SKIA has received US Food and Drug Administration (FDA) 510(k) clearance for its augmented reality (AR) surgical guidance system, SKIA HEAD.
The regulatory clearance clears the path for SKIA’s commercial debut in the United States, where the company plans to enter the market through a strategic partnership with hardware provider Structure.
Unlike conventional surgical navigation systems that often rely on bulky, stationary equipment, SKIA HEAD is designed as a compact, tablet-based platform. The system converts preoperative medical imaging data into high-fidelity 3D anatomical reconstructions and projects them directly onto the patient’s body in real time. This allows surgeons to see beyond the surface and into the patient’s internal anatomy.
SKIA HEAD is powered by Structure’s medical-grade scanning sensors, known as Structure Sensors, which accurately map a patient’s physical environment and anatomy, ensuring the AR overlay remains perfectly aligned during the procedure.
By combining Structure’s established sensor ecosystem and SKIA’s software expertise, the two companies aim to make intuitive, high-precision AR guidance a standard in American operating rooms.
“FDA 510(k) clearance validates that our technology meets stringent regulatory requirements and is suitable for efficient clinical workflow support. This milestone, combined with our partnership with Structure, accelerates our efforts to bring practical AR guidance to the global surgical community,” said CEO Jong-Myoung Lee.
The companies believe the technology could help reduce dependence on expensive, room-filling hardware and make advanced AR capabilities more accessible to smaller hospitals and outpatient centers across the US.
While SKIA HEAD is the latest to receive US clearance, SKIA already has an international footprint. The company said its SKIA Body solution has been used in more than 80 hernia procedures in India.
Domestically, the company has received two Korea Ministry of Food and Drug Safety (KMFDS) approvals for SKIA Body and SKIA Face. It is also conducting a confirmatory clinical trial for SKIA Breast in collaboration with leading institutions including Seoul National University, Yonsei Severance, and Ewha Womans University Hospital.
Additionally, Skia is developing AR platforms for breast cancer surgery, gastrointestinal operations, and even forensic applications.
