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. This regulatory milestone clears the path for the system’s commercial debut in the United States, supported by a strategic hardware partnership.
SKIA HEAD, a tablet-based AR surgical guidance system that allows surgeons to see beyond the surface.
Precision Meets Portability
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.
A Strategic U.S. Launch
The FDA clearance is not just a regulatory win but a commercial catalyst. SKIA has confirmed it is planning to enter the U.S. market through a formal partnership with Structure. By leveraging 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,” said CEO Jong-Myoung Lee. “This milestone, combined with our partnership with Structure, accelerates our efforts to bring practical AR guidance to the global surgical community.”
Proven Clinical Success
While SKIA HEAD is the latest to receive U.S. clearance, the company’s technology is already battle-tested:
- International Footprint: In India, the company’s SKIA Body solution has successfully assisted in over 80 hernia surgeries.
- Domestic Achievements: SKIA has already received 2 KMFDS approvals for SKIA Body and SKIA Face. It is now conducting a confirmatory clinical trial for SKIA Breast with Seoul National University, Yonsei Severance, and Ewha Womans University Hospital.
- Diverse Applications: SKIA is currently developing AR platforms for breast cancer surgery, gastrointestinal operations, and even forensic applications.
By eliminating the need for specialized, room-filling hardware, SKIA and Structure are positioned to offer a more accessible, cost-effective alternative to traditional surgical navigation, potentially bringing advanced AR capabilities to smaller hospitals and outpatient centers across the U.S.
