South Korean medical technology company SKIA has received the US Food and Drug Administration (FDA) 510(k) clearance for SKIA HEAD, its augmented reality (AR) surgical guidance system.
The clearance paves the way for Skia to launch the tablet-based platform commercially in the US, with the company confirming plans to enter the market via a partnership with hardware provider Structure.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
SKIA HEAD employs a software system that turns preoperative imaging into three-dimensional reconstructions, which are projected onto patients’ bodies in real-time.
The platform operates on a tablet rather than fixed equipment and is supported by medical-grade Structure Sensors, which scan and map both the patient and the surrounding surgical environment.
This technology is intended to help maintain accurate alignment of anatomical overlays for surgeons.
Skia stated that its collaboration with Structure aims to combine the sensor developer’s hardware ecosystem with Skia’s software capabilities, seeking to introduce AR surgical guidance in US operating rooms.
Skia CEO Jong-Myoung Lee said: “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.”
Internationally, Skia has reported that its SKIA Body solution has been used in more than 80 hernia procedures in India.
Domestically, the medtech company has obtained two Korea Ministry of Food and Drug Safety (KMFDS) approvals for SKIA Body and SKIA Face and is conducting a further clinical trial for SKIA Breast at several major hospitals in South Korea.
Skia is also developing additional AR applications for surgical fields, including breast cancer and gastrointestinal procedures, as well as forensic purposes.
The company and Structure anticipate that the tablet-based, sensor-driven AR system could offer an alternative to conventional surgical navigation systems, particularly in smaller US hospitals and outpatient settings, by reducing dependency on specialised large-scale equipment.
