Stereotaxis Announces EU Launch and 510(k) Submission for Synchrony System to Modernize Interventional Cath Labs

Core Insights - Stereotaxis has received CE Mark approval in Europe and submitted a 510(k) application to the FDA for its Synchrony™ system, which is aimed at modernizing interventional cath labs [1][2]. Product Features - The Synchrony system features a 55" 4K ultra-high-definition display that integrates various systems in the cath lab, enhancing the procedure experience with custom layouts and streamlined workflows [2]. - Synchrony digitizes video streams with high fidelity and minimal latency, providing clear visualization, and is designed to protect against obsolescence as new technologies emerge [2]. - The system is complemented by SynX™, a cloud-based application that ensures secure remote connectivity and collaboration, compliant with HIPAA and GDPR [2]. Expert Opinions - Experts in the field have praised Synchrony and SynX for their advanced hardware and software architecture, which promises improved intraoperative experiences and better equipment reliability [3]. - The technology is seen as a solution for enhancing remote connectivity and collaboration in electrophysiology labs, facilitating better patient care and training for future physicians [3]. Strategic Importance - The Synchrony and SynX systems are central to Stereotaxis's digital surgery initiatives, aimed at improving workflow and enabling remote robotic procedures [4]. - The company believes that the benefits of these technologies extend beyond robotic labs to all cath labs, enhancing overall connectivity and collaboration [4]. Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular interventions, with a mission to develop robotic systems that improve patient care and operational efficiency in interventional laboratories [5]. - The company's technology has been utilized to treat over 150,000 patients globally, underscoring its impact in the healthcare sector [5].