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Captiva Spine Announces FDA Clearance for Flat Panel C-Arm Imaging Calibrators and AI-Assisted Registration for WatchTower Spine Navigation, Improved Efficiency, Reduced Radiation, and Future-Proof Access

Editor's by Editor's
November 15, 2025
in Spine
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Captiva Spine Announces FDA Clearance for Flat Panel C-Arm Imaging Calibrators and AI-Assisted Registration for WatchTower Spine Navigation, Improved Efficiency, Reduced Radiation, and Future-Proof Access

Today’s installations demand enabling technologies that integrate seamlessly into existing workflows without increasing costs or requiring new infrastructure. The WatchTower Spine navigation system was designed around this philosophy: easy setup, familiar visuals, and precise guidance without interruption to your workflow.

JUPITER, FL – November 14, 2025 /OrthoSpineNews/ – In an era where technology is rapidly reshaping spine surgery and contributing to the standard of care in the spine, navigation platforms still struggle to strike a balance between accuracy and practicality, especially in ambulatory settings where cost, space and radiation exposure are most critical. Captiva Spine® is addressing this challenge head-on with a series of advancements to its WatchTower® spinal navigation system, with the goal of making spinal navigation easier and more accessible in the next generation of surgical environments.

Captiva Spine announced 510(k) clearance from the US Food and Drug Administration (FDA) for new 21 cm and 31 cm flat panel C-arm imaging calibrators and AI-assisted 2D to 3D image registration. For its WatchTower Spine navigation system, these are advancements that further define the essential role of enabling technology.

The Challenge: Balancing Accuracy, Practicality, and Cost

For years, spine navigation has struggled with the balance between precision and practicality. High-cost CT-based systems offer accuracy but introduce complexity, time, and radiation exposure, factors that can slow adoption and limit accessibility.

Today’s installations demand enabling technologies that integrate seamlessly into existing workflows without increasing costs or requiring new infrastructure. The WatchTower Spine navigation system was designed around this philosophy: easy setup, familiar visuals, and precise guidance without interruption to your workflow.

The solution: real-time 3D navigation using the C-arm at its center

WatchTower transforms standard C-arm fluoroscopy into a real-time 3D navigation environment, eliminating the need for intraoperative CT. With newly approved flat panel calibrators, the system now supports the latest square detector C-arms providing sharper, lower dose images.

This release expands compatibility while maintaining support for 9″ and 12″ round C-arm image intensifiers, ensuring continuity for all users. By combining real-time navigation with lower radiation and greater hardware compatibility, WatchTower continues to build on security and scalability.

“These authorizations go beyond simple compatibility; they reaffirm Captiva’s commitment to keeping facilities at the cutting edge,” said Dale Mitchell, president of Captiva Spine. “As imaging evolves, WatchTower evolves with it; whether using round or flat panel detectors, surgeons can expect consistent accuracy and an even safer environment for their teams and patients.”

AI Assisted Registration – Smart Alignment

The newly approved AI-assisted image registration is more than a feature; It is the foundation for Captiva Spine’s next-generation software environment (UI/UX). This AI alignment engine automates key steps while maintaining surgeon control and verification, reducing operator dependency and improving consistency.

This next phase of WatchTower software is planned to debut commercially in 2026, along with a redesigned user interface and workflow improvements focused on faster setup and intuitive intraoperative guidance.

“Our development path has always been surgeon-led,” said Erik Gottschalk, director of sales. “Each update addresses what surgeons need in real-world practice: fewer steps, faster registration, and adaptive imaging options. The use of AI capabilities dramatically improves scalability, allowing for less dependence on the technical operator, and is even easier to use at the point of use.”

A surgeon’s perspective: precision without complexity

Captiva Spine Announces FDA Clearance for Flat Panel C-Arm Imaging Calibrators and AI-Assisted Registration for WatchTower Spine Navigation, Improved Efficiency, Reduced Radiation, and Future-Proof Access

Simon Chao, MD, orthopedic spine surgeon at University Orthopedics

“WatchTower has become an essential part of my workflow,” said Simon Chao, MD, an orthopedic spine surgeon at University Orthopedics serving the greater Boston, MA area. “It is reliable, accurate and fully compatible with the imaging systems we already use. The addition of flat panel integration further reduces radiation without altering the way we operate, allowing WatchTower to be utilized in more facilities using this new version of C-arm fluoroscopy.”

This alignment between surgeon expertise and system design underscores a broader trend: enabling technology succeeds when it simplifies, rather than replaces, existing processes and workflows. The market favors systems that are intuitive, open and scalable, those that can be adopted without disrupting established routines.

Beyond Column Navigation: A Complete Portfolio of Column Solutions

Captiva Spine’s commitment to enabling technology extends beyond navigation. The company offers a comprehensive portfolio of spine solutions, including cervical fixation and interbody cages, lumbar fixation, expandable cages, and sacroiliac joint fusion systems.

This complete continuum of care allows Captiva to offer integrated solutions, from planning and navigation to final fixation, making the company a unique partner for hospitals and ASCs seeking clinical and economic value.

“We offer a complete ecosystem of spine solutions supported by enabling technology that improves efficiency, safety and access. Navigation enhances every implant we make, and every implant reinforces the value of navigation,” Mitchell added.

Mobility, openness and economic efficiency

The WatchTower ROAM Spine navigation system configuration offers full-featured navigation in a compact, mobile footprint, making it ideal for hospitals and ASCs. With rapid setup and open platform compatibility between implant systems, ROAM supports procedural flexibility, from cervical and lumbar fusion to sacroiliac joint fixation, all without relying on proprietary robotics or specialized infrastructure.

In a climate where capital budgets are under pressure, WatchTower offers a pragmatic way forward, offering advanced navigation that adapts to existing environments, staff and equipment.

Captiva Spine will introduce the WatchTower ROAM Spine Navigation System at the North American Spine Society (NASS) 2025 Annual Meeting in Denver, Colorado, November 14-16. Attendees will have the opportunity to experience firsthand WatchTower’s unique combination of adaptability, precision and real-time 3D backbone navigation.

About Captiva Spine, Inc.
Captiva Spine, founded in 2007, is a privately held medical device company that brings together healthcare providers, distribution professionals and surgical facilities with innovative spine care solutions. With a focus on quality, Captiva Spine strives to develop reliable systems that offer clinical and economical solutions to the spine market.

Captiva Spine: sailing today.

__________

SEE MORE DETAILS

Captiva, a privately held organization, has recently unlocked strategic investment opportunities and continues to build distribution partnerships, building on its current momentum to expand its market share in 2025 and beyond. For investment or distribution inquiries, please contact us at info@captivaspine.com.

__________

This press release also appears on PrWeb.com; TheSpineMarketGroup.com;

by Captiva Spine

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