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SKIA secures FDA 510(k) clearance for AR surgical platform
South Korean medical technology company SKIA has received FDA 510(k) clearance for its SKIA HEAD, its AR surgical guidance system. SKIA HEAD uses software that transforms preoperative images into 3D reconstructions, projecting them onto patients’ bodies in real-time. SKIA HEAD operates on a tablet, supported by Structure Sensors that scan and map the patient and environment. Credit: SKIA / PRNewswire. 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…
South Korean medical technology company SKIA has received FDA 510(k) clearance for its SKIA HEAD, its AR surgical guidance system.
Source: Medical Device Network