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

Business

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

Business

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

2026-05-29 21:00 Last Updated At:21:25

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.

** This press release is distributed by PR Newswire through automated distribution system, for which the client assumes full responsibility. **

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

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

The world's first dedicated refrigerator failsafe receives global honors as its $2M Kickstarter campaign enters the final countdown.

LOS ANGELES, May 30, 2026 /PRNewswire/ -- Clean energy pioneer BLUETTI has earned Frost & Sullivan recognition for FridgePower, the world's first ultra-slim backup power system purpose-built for refrigerators*. Surpassing $2 million in funding, the Kickstarter campaign concludes May 31—marking the final window for early-bird pricing before global shipping and the official retail launch begin in June.

The FridgePower addresses the inherent vulnerability of modern kitchens to unpredictable outages. This ultra-slim, automatic backup provides seamless 24/7 protection—preventing food spoilage during overnight failures or when the home is unattended. Industry experts have recognized this dedicated utility, highlighting its plug-and-play simplicity and a refrigeration-specific UPS protocol that offers enhanced reliability compared to general-purpose portable power stations.
 

FridgePower Stories from the Field

  • The $4,100 Beef Defense: Protecting High-Stakes Assets

    In a high-stakes test of grid independence, 20-year IBEW electrician Kyle partnered with Jordan, a professional chiropractor, to protect a critical asset: 456 lbs of premium beef valued at $4,100. By quickly deploying the FridgePower and a BlueCell 200 expansion battery, they simulated a grid failure test. The system's 10ms UPS transition was so instantaneous that Jordan noted "not even a flicker" from the appliances. This professional-grade redundancy transformed a potential $4,100 loss into total household peace of mind.
     

  • The Fridge-Focused Solution: TechRadar & pv magazine's Technical Validation

    Leading voices from TechRadar (4.5/5 score) have hailed the FridgePower for bridging the gap between rugged backup gear and expensive whole-home backup systems. Jack highlighted the appliance-first philosophy, noting that the 75mm ultra-slim profile and off-white colour feels far closer to a modern home appliance than a 2kWh power station. This aesthetic is backed by deep-layer engineering; pv magazine/ESS News' technical review focused on the bypass-first architecture and idle power draw, which prioritizes direct power flow to the fridge to extend battery life. Tristan concluded that the FridgePower offers a simpler way to secure the most important part of a house, making it an ideal energy solution not just for homeowners, but for those who rent or lease as well.
     

  • A Strategy for Hurricane Readiness: CleanTechnica's First-Hand Review

    Based in Florida's hurricane-prone coast, Zachary Shahan of CleanTechnica highlighted the FridgePower's unique convenience compared to traditional home battery backups. He noted the common struggle of power outages: "It can be a real hassle to pull a refrigerator out every time... then push that big fridge back in place." By staying permanently connected, FridgePower eliminates this frustration. Beyond the sleek design, Zachary emphasized the practical resilience of the Extreme Weather Alert feature, which monitors local forecasts to automatically top off the battery ahead of predicted storms.

A Mission Driven by BLUETTI Community

"Our community's feedback highlights a clear gap: while portable power stations can run a fridge, they often require manual intervention during a crisis," said James Ray, spokesperson for BLUETTI. "We engineered FridgePower to eliminate that friction—providing a specialized, automatic backup that stays ready 24/7 so homeowners don't have to lift a finger when the lights go out. Combined with the Frost & Sullivan recognition, this reinforces our mission: delivering smarter, mission-critical energy solutions for the modern home."

Final 72 Hours on Kickstarter

The BLUETTI FridgePower Kickstarter campaign concludes May 31. Global shipping and full availability will commence in June 2026. This marks the final window to secure exclusive Early Bird pricing before retail rates apply:

  • FridgePower Solo: $819 (37% off MSRP)
  • FridgePower + BlueCell 200 Combo: $1,468 (41% off MSRP)

*Certified by Frost & Sullivan (April 2026)

About BLUETTI

Established in 2013, BLUETTI has evolved into a pioneer in the clean energy sector. Driven by robust in-house R&D and sustainable innovation, the brand empowers millions across 120+ countries to stay safe and prepared. Its portfolio of solar generators and home battery backup solutions ensures reliable power for emergency preparedness, RV travel, and  off-grid lifestyles.

Media Contact

Ellen Lee
PR Lead, U.S. Market
ellenlee@bluetti.com

The world's first dedicated refrigerator failsafe receives global honors as its $2M Kickstarter campaign enters the final countdown.

LOS ANGELES, May 30, 2026 /PRNewswire/ -- Clean energy pioneer BLUETTI has earned Frost & Sullivan recognition for FridgePower, the world's first ultra-slim backup power system purpose-built for refrigerators*. Surpassing $2 million in funding, the Kickstarter campaign concludes May 31—marking the final window for early-bird pricing before global shipping and the official retail launch begin in June.

The FridgePower addresses the inherent vulnerability of modern kitchens to unpredictable outages. This ultra-slim, automatic backup provides seamless 24/7 protection—preventing food spoilage during overnight failures or when the home is unattended. Industry experts have recognized this dedicated utility, highlighting its plug-and-play simplicity and a refrigeration-specific UPS protocol that offers enhanced reliability compared to general-purpose portable power stations.
 

FridgePower Stories from the Field

  • The $4,100 Beef Defense: Protecting High-Stakes Assets

    In a high-stakes test of grid independence, 20-year IBEW electrician Kyle partnered with Jordan, a professional chiropractor, to protect a critical asset: 456 lbs of premium beef valued at $4,100. By quickly deploying the FridgePower and a BlueCell 200 expansion battery, they simulated a grid failure test. The system's 10ms UPS transition was so instantaneous that Jordan noted "not even a flicker" from the appliances. This professional-grade redundancy transformed a potential $4,100 loss into total household peace of mind.
     

  • The Fridge-Focused Solution: TechRadar & pv magazine's Technical Validation

    Leading voices from TechRadar (4.5/5 score) have hailed the FridgePower for bridging the gap between rugged backup gear and expensive whole-home backup systems. Jack highlighted the appliance-first philosophy, noting that the 75mm ultra-slim profile and off-white colour feels far closer to a modern home appliance than a 2kWh power station. This aesthetic is backed by deep-layer engineering; pv magazine/ESS News' technical review focused on the bypass-first architecture and idle power draw, which prioritizes direct power flow to the fridge to extend battery life. Tristan concluded that the FridgePower offers a simpler way to secure the most important part of a house, making it an ideal energy solution not just for homeowners, but for those who rent or lease as well.
     

  • A Strategy for Hurricane Readiness: CleanTechnica's First-Hand Review

    Based in Florida's hurricane-prone coast, Zachary Shahan of CleanTechnica highlighted the FridgePower's unique convenience compared to traditional home battery backups. He noted the common struggle of power outages: "It can be a real hassle to pull a refrigerator out every time... then push that big fridge back in place." By staying permanently connected, FridgePower eliminates this frustration. Beyond the sleek design, Zachary emphasized the practical resilience of the Extreme Weather Alert feature, which monitors local forecasts to automatically top off the battery ahead of predicted storms.

In a high-stakes test of grid independence, 20-year IBEW electrician Kyle partnered with Jordan, a professional chiropractor, to protect a critical asset: 456 lbs of premium beef valued at $4,100. By quickly deploying the FridgePower and a BlueCell 200 expansion battery, they simulated a grid failure test. The system's 10ms UPS transition was so instantaneous that Jordan noted "not even a flicker" from the appliances. This professional-grade redundancy transformed a potential $4,100 loss into total household peace of mind.
 

Leading voices from TechRadar (4.5/5 score) have hailed the FridgePower for bridging the gap between rugged backup gear and expensive whole-home backup systems. Jack highlighted the appliance-first philosophy, noting that the 75mm ultra-slim profile and off-white colour feels far closer to a modern home appliance than a 2kWh power station. This aesthetic is backed by deep-layer engineering; pv magazine/ESS News' technical review focused on the bypass-first architecture and idle power draw, which prioritizes direct power flow to the fridge to extend battery life. Tristan concluded that the FridgePower offers a simpler way to secure the most important part of a house, making it an ideal energy solution not just for homeowners, but for those who rent or lease as well.
 

Based in Florida's hurricane-prone coast, Zachary Shahan of CleanTechnica highlighted the FridgePower's unique convenience compared to traditional home battery backups. He noted the common struggle of power outages: "It can be a real hassle to pull a refrigerator out every time... then push that big fridge back in place." By staying permanently connected, FridgePower eliminates this frustration. Beyond the sleek design, Zachary emphasized the practical resilience of the Extreme Weather Alert feature, which monitors local forecasts to automatically top off the battery ahead of predicted storms.

A Mission Driven by BLUETTI Community

"Our community's feedback highlights a clear gap: while portable power stations can run a fridge, they often require manual intervention during a crisis," said James Ray, spokesperson for BLUETTI. "We engineered FridgePower to eliminate that friction—providing a specialized, automatic backup that stays ready 24/7 so homeowners don't have to lift a finger when the lights go out. Combined with the Frost & Sullivan recognition, this reinforces our mission: delivering smarter, mission-critical energy solutions for the modern home."

Final 72 Hours on Kickstarter

The BLUETTI FridgePower Kickstarter campaign concludes May 31. Global shipping and full availability will commence in June 2026. This marks the final window to secure exclusive Early Bird pricing before retail rates apply:

  • FridgePower Solo: $819 (37% off MSRP)
  • FridgePower + BlueCell 200 Combo: $1,468 (41% off MSRP)

*Certified by Frost & Sullivan (April 2026)

About BLUETTI

Established in 2013, BLUETTI has evolved into a pioneer in the clean energy sector. Driven by robust in-house R&D and sustainable innovation, the brand empowers millions across 120+ countries to stay safe and prepared. Its portfolio of solar generators and home battery backup solutions ensures reliable power for emergency preparedness, RV travel, and  off-grid lifestyles.

Media Contact

Ellen Lee
PR Lead, U.S. Market
ellenlee@bluetti.com

** This press release is distributed by PR Newswire through automated distribution system, for which the client assumes full responsibility. **

BLUETTI FridgePower Hits $2M Milestone and Global Award Ahead of Retail Launch

BLUETTI FridgePower Hits $2M Milestone and Global Award Ahead of Retail Launch

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