SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership
Summary
SKIA has secured FDA 510(k) clearance for SKIA HEAD, its tablet-based augmented reality surgical guidance system. The clearance opens the door for a U.S. launch, and the company plans to expand through a partnership with Structure. SKIA HEAD turns preoperative medical imaging into real-time 3D anatomical overlays to help surgeons navigate procedures with greater precision. The company says its sensor-powered platform can replace bulky navigation hardware and support more accessible surgical workflows. SKIA also points to existing clinical use in India and additional regulatory approvals in South Korea as evidence of traction.
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AI & Machine learning
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Medical Software
SaaS
Healthtech
