Captiva Spine Announces FDA Clearance for Flat-Panel C-Arm Image Calibrators and AI-Assisted Registration for WatchTower Spine Navigation, Advancing Efficiency, Radiation Reduction, and Future-Ready Access

Today’s facilities demand enabling technologies that integrate seamlessly into existing workflows without driving up costs or requiring new infrastructure. The WatchTower Spine Navigation System was designed around this philosophy: simple setup, familiar imaging, and precise guidance without workflow disruption.

JUPITER, FL – November 2025 — In an era when technology is rapidly reshaping spine surgery and contributing to the standard of care in spine, navigation platforms still struggle to strike a balance between precision and practicality, especially in outpatient 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® Spine Navigation System, aiming to make spine navigation more straightforward and accessible in the next generation of surgical environments.

Captiva Spine announced U.S. Food and Drug Administration (FDA) 510(k) clearance for new 21 cm and 31 cm Flat-Panel C-Arm Image 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 Precision, Practicality, and Cost

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

Today’s facilities demand enabling technologies that integrate seamlessly into existing workflows without driving up costs or requiring new infrastructure. The WatchTower Spine Navigation System was designed around this philosophy: simple setup, familiar imaging, and precise guidance without workflow disruption.

The Solution: Real-Time 3D Navigation Using the C-Arm Your Facility Owns

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

This release extends 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 broader hardware compatibility, WatchTower continues to build on both safety and scalability.

“These clearances go beyond simple compatibility; they reaffirm Captiva’s commitment to keeping facilities ahead of the curve,” 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 precision and an even safer environment for their teams and patients.”

AI-Assisted Registration: Intelligent Alignment

The newly cleared AI-assisted image registration is more than a feature; it is a 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 targeted to debut commercially in 2026, alongside a redesigned user interface and workflow enhancements focused on faster setup and intuitive intraoperative guidance.

“Our development path has always been surgeon-led,” said Erik Gottschalk, Director of Sales. “Each update responds to what surgeons need in real practice: fewer steps, faster registration, and adaptable imaging options. The use of AI capabilities dramatically improves scalability, allowing less dependency on the technical operator, and is even more user-friendly at the point of use.”

A Surgeon’s Perspective: Precision Without Complexity

“WatchTower has become an essential part of my workflow,” said Simon Chao, MD, Orthopedic Spine Surgeon at University Orthopedics serving the greater Boston, MA area. “It’s reliable, precise, and fully compatible with the imaging systems we already use. The addition of flat-panel integration further reduces radiation without altering how we operate, enabling WatchTower utilization at more facilities using this newer version of C-Arm fluoroscopy.”

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

Beyond Spine Navigation: A Complete Spine Solutions Portfolio

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

This full continuum of care allows Captiva to deliver integrated solutions, from planning and navigation to final fixation, making the company a single-source partner for hospitals and ASCs seeking both clinical and economic value.

“We provide a complete ecosystem of spinal 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,” added Mitchell.

Mobility, Openness, and Economic Efficiency

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

In a climate where capital budgets are under pressure, WatchTower provides a pragmatic path forward, offering advanced navigation that fits within existing environments, staffing, and equipment.

Captiva Spine will showcase 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 WatchTower’s unique combination of adaptability, precision, and real-time 3D spine navigation firsthand.

About Captiva Spine, Inc.

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

Captiva Spine – Navigating Today.

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

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