DIXI medical is pleased to announce that a regulatory submission (510(k)) for its first proprietary thermocoagulation system, SEEG‑Tx®,was filed this week with the U.S. Food and Drug Administration (FDA). This milestone reflects a major step forward in bringing a transformative, next-generation technology available to clinicians in the United States.

The SEEG Tx® system is designed to deliver highly consistent bipolar ablation volumes through dynamic, real‑time power control, ensuring stable energy delivery.

Building on decades of SEEG expertise, DIXI medical integrated insights from extensive preclinical research, bench testing, and laboratory simulations to support the 510(k) submission.

Designed for seamless integration into the SEEG workflow, SEEG‑Tx® is designed to empower clinicians with:

• Closed-loop automation that supports consistent and controlled ablations
• Streamlined ergonomics and intuitive interface
• Clinical workflow efficiency through a fully SEEG-compatible architecture
• Stability and safety features developed through rigorous engineering and lab validation
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SEEG‑Tx® is intended to support clinicians performing SEEG‑guided thermocoagulation by offering a fully integrated solution engineered to enhance procedural control, optimize workflow, and reinforce consistency in epilepsy care settings.

Submitting SEEG‑Tx® to the FDA marks a significant milestone on the path toward making this technology available to clinicians and patients in the United States. While initial availability will focus on the U.S. market, DIXI medical has already received strong interest internationally and will assess future expansion as regulatory pathways evolve.

This submission represents the culmination of intensive R&D efforts, including collaborative design cycles with clinicians, extensive lab work, and comprehensive system validation, that shaped SEEG‑Tx® from concept to clinical reality.

“SEEG‑Tx® was built hand in hand with clinicians who challenged us to rethink thermocoagulation,” said John Gale, Chief Scientific Officer. “Reaching this regulatory milestone is a major step toward delivering a system designed around real clinical practice. We look forward to working closely with the FDA as we advance toward U.S. availability.”

DIXI medical will share additional updates as the FDA review progresses and as new milestones are achieved. Healthcare professionals and partners interested in learning more about SEEG‑Tx® or exploring future collaboration opportunities are invited to contact info@diximedical.com.

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