# SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership

- Link: https://www.thailand-business-news.com/pr-news/skia-head-ar-surgical-guidance-receives-fda-510k-clearance-eyes-u-s-expansion-with-structure-partnership
- Published: 2026-05-29T20:00:00+07:00
- Author: PR Newswire

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.⌉⌊SKIA HEAD, a tablet-based AR surgical guidance system that
allows surgeons to see beyond the surface.⌉[
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.

---

  |  This article was produced by Cision PR Newswire, our trusted news partner. The views expressed and the content presented here are solely those of the author and may not fully reflect the opinions of Thailand Business News. |

---

 
**Read the original article :** [SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance, Eyes U.S. Expansion with Structure Partnership ](http://www.prnasia.com/story/archive/4969985_CN69985_0?rand=184833)