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.
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.
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SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership
CAPE TOWN, South Africa, Sept. 16, 2026 /PRNewswire/ -- GameChange Energy, a global provider of renewable energy infrastructure solutions, announced the completion of its Genius Tracker™ 1P system for the 283 MWp Mooi Plaats Solar PV Plant in South Africa, one of the country's largest single-site solar power projects. The project forms part of the Koruson 2 renewable energy cluster and was developed and constructed by Envusa Energy, the renewable energy joint venture between EDF Power Solutions and Anglo American, with CEEC/CGGC serving as EPC contractor.
Located near Noupoort in the Northern Cape, the Mooi Plaats Solar PV Plant will supply renewable electricity to Anglo American's mining operations in South Africa, including Kumba Iron Ore and De Beers as well as Valterra Platinum, supporting long-term decarbonisation and energy resilience objectives across the mining sector.
"The Northern Cape region presents harsh environmental and site conditions, including high wind exposure, elevated temperatures, dusty conditions, and demanding construction environments that place significant demands on tracker design and execution. Our Genius Tracker™ 1P system was selected to support reliable performance under these conditions while enabling efficient installation across a project of this scale. We appreciate the strong collaboration with CGGC, Envusa Energy, and the broader project team throughout execution of this important development," said Vikas Bansal, CEO – International at GameChange Energy.
The project is expected to generate nearly 360 million kWh of renewable electricity annually while contributing to long-term reductions in Scope 2 emissions associated with mining operations. During construction, the project supported more than 1,600 jobs and included approximately R20 million in socio-economic development investment for surrounding communities.
"Mooi Plaats Solar PV Plant is a significant renewable energy infrastructure project both in terms of scale and execution complexity. Delivery of a project of this nature requires coordination across multiple stakeholders, technologies, and construction activities, and we appreciate the partnership with GameChange Energy throughout the tracker installation phase," said Hanli Smit, Head of Execution, Envusa Energy.
About GameChange Energy
GameChange Energy is a global energy infrastructure company delivering integrated, highly engineered solutions for utility-scale renewable energy and critical power applications. Through our portfolio of operating companies, we provide solar trackers, fixed-tilt mounting systems, eBOS solutions, transformers, drone-based asset monitoring, and customized infrastructure solutions for renewable energy plants, data centers, and battery energy storage systems (BESS). Our technologies are designed to reduce risk, improve performance, and deliver reliable operation worldwide. GameChange Energy is engineering the future of clean energy infrastructure.
For more information about GameChange Energy, visit: www.gamechangeenergy.com
Media Contact
Nisha Wadhwani
Lead – Marketing, GameChange Energy
nisha.wadhwani@gamechangeenergy.com
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GameChange Energy completes commissioning of its Genius Tracker™ for the landmark Mooi Plaats Solar PV project
