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Stereotaxis Rolls Out Synchrony System in EU and Files for FDA Approval
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Key Takeaways
{\"0\":\"Stereotaxis launched its Synchrony system in Europe and filed for FDA 510(k) clearance in the U.S.\",\"1\":\"Synchrony integrates lab visuals and controls into one digital interface with cloud connectivity via SynX.\",\"2\":\"The system supports future AI automation and remote robotics, aligning with STXS\' digital surgery vision.\"}
Stereotaxis (STXS - Free Report) announced last week the European launch and U.S. FDA 510(k) submission of its Synchrony system, a next-generation platform designed to modernize interventional cath labs. The system integrates all lab visuals and controls into a single digital interface, offering enhanced workflow, clearer visualization and improved connectivity through its companion cloud app, SynX.
The launch marks a strategic step in Stereotaxis’ push to expand beyond robotic navigation into broader digital surgery solutions. By streamlining operations and enabling remote collaboration, Synchrony could strengthen Stereotaxis’ footprint across both robotic and non-robotic cath labs, opening new revenue channels while reinforcing its leadership in surgical innovation.
More on the News
Synchrony is built to digitize and modernize the interventional cath lab environment, featuring a 55-inch ultra-high-definition 4K display that unifies multiple system feeds into one seamless interface. The platform delivers full-fidelity video streams with near-zero latency and supports custom layouts to streamline physician workflows. It also comes integrated with SynX, a secure cloud-based application compliant with HIPAA and GDPR standards. SynX enables remote connectivity, collaboration, recording and real-time monitoring, providing physicians and administrators with centralized control over their lab operations.
The company emphasized that Synchrony and SynX are designed as foundational platforms capable of supporting future advancements, including AI-driven automation and long-distance robotic procedures. The system architecture is built to remain compatible with upcoming technologies, offering obsolescence protection for hospitals and labs. According to Stereotaxis, this initiative aligns with its long-term digital surgery vision by enhancing workflow efficiency, improving remote access and strengthening interoperability across global cath labs.
The CE Mark approval in Europe allows Stereotaxis to begin commercial rollout of Synchrony across EU markets. At the same time, the company’s 510(k) submission to the FDA positions it for potential entry into the American market pending clearance. These dual regulatory steps not only expand Stereotaxis’ geographic reach but also create a pathway for accelerated adoption of its digital surgery solutions.
Latest Updates From STXS’s Peers
STXS competes with several leading players in the surgical robotics and interventional technology space that are advancing automation, precision, and connectivity in operating rooms and cath labs. Here’s a look at the latest developments from some of Stereotaxis’ key peers:
Intuitive Surgical (ISRG - Free Report) has advanced its innovation roadmap with the rollout of new software features for the da Vinci 5 platform, including real-time visualization and enhanced force feedback for surgeons. ISRG also expanded its Ion endoluminal platform by integrating advanced imaging and AI tools to improve accuracy in minimally invasive lung procedures. These updates reinforce ISRG’s position as a technology leader in robotic-assisted surgery.
In addition, ISRG recently secured CE Mark approval for the da Vinci 5 system in Europe, enabling a broader international rollout. Intuitive Surgical also gained FDA clearance for its Vessel Sealer Curved instrument, further expanding its instrument lineup. With more than 300 new da Vinci system placements reported in recent quarters, ISRG continues to scale its footprint and strengthen its recurring revenue base.
Microbot Medical (MBOT - Free Report) achieved a key milestone with FDA clearance for its LIBERTY Endovascular Robotic System, the first single-use, remotely operated platform cleared for peripheral vascular use. MBOT plans a limited market launch in the fourth quarter of 2025, showcasing the system at the upcoming Symposium on Clinical Interventional Oncology. This debut underscores MBOT’s move from development to commercialization in the endovascular robotics market.
To support its commercial rollout, MBOT has partnered with a U.S.-based logistics provider for inventory and distribution management. MBOT also continues to strengthen its intellectual property portfolio, having recently secured a new patent for a modular robotic surgical system. These developments place MBOT in a stronger position to compete within the growing landscape of robotic-assisted vascular interventions.
PROCEPT BioRobotics (PRCT - Free Report) continues to gain traction with its Aquablation therapy for the treatment of benign prostatic hyperplasia (BPH). In 2025, PRCT achieved a major regulatory milestone with a new Category I CPT code for Aquablation, replacing its previous Category III designation and improving reimbursement prospects. PRCT’s systems are now seeing wider adoption across U.S. hospitals and ambulatory surgical centers.
In its latest update, PRCT reported strong revenue growth, placing 51 new systems in the second quarter of 2025 while expanding gross margins to 65 %. PRCT is also conducting the WATER IV trial to explore Aquablation’s use in prostate cancer within ambulatory surgery settings. With rising clinical validation and growing procedural volume, PRCT remains well-positioned to scale its robotic urology platform.
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Stereotaxis Rolls Out Synchrony System in EU and Files for FDA Approval
Key Takeaways
Stereotaxis (STXS - Free Report) announced last week the European launch and U.S. FDA 510(k) submission of its Synchrony system, a next-generation platform designed to modernize interventional cath labs. The system integrates all lab visuals and controls into a single digital interface, offering enhanced workflow, clearer visualization and improved connectivity through its companion cloud app, SynX.
The launch marks a strategic step in Stereotaxis’ push to expand beyond robotic navigation into broader digital surgery solutions. By streamlining operations and enabling remote collaboration, Synchrony could strengthen Stereotaxis’ footprint across both robotic and non-robotic cath labs, opening new revenue channels while reinforcing its leadership in surgical innovation.
More on the News
Synchrony is built to digitize and modernize the interventional cath lab environment, featuring a 55-inch ultra-high-definition 4K display that unifies multiple system feeds into one seamless interface. The platform delivers full-fidelity video streams with near-zero latency and supports custom layouts to streamline physician workflows. It also comes integrated with SynX, a secure cloud-based application compliant with HIPAA and GDPR standards. SynX enables remote connectivity, collaboration, recording and real-time monitoring, providing physicians and administrators with centralized control over their lab operations.
The company emphasized that Synchrony and SynX are designed as foundational platforms capable of supporting future advancements, including AI-driven automation and long-distance robotic procedures. The system architecture is built to remain compatible with upcoming technologies, offering obsolescence protection for hospitals and labs. According to Stereotaxis, this initiative aligns with its long-term digital surgery vision by enhancing workflow efficiency, improving remote access and strengthening interoperability across global cath labs.
The CE Mark approval in Europe allows Stereotaxis to begin commercial rollout of Synchrony across EU markets. At the same time, the company’s 510(k) submission to the FDA positions it for potential entry into the American market pending clearance. These dual regulatory steps not only expand Stereotaxis’ geographic reach but also create a pathway for accelerated adoption of its digital surgery solutions.
Latest Updates From STXS’s Peers
STXS competes with several leading players in the surgical robotics and interventional technology space that are advancing automation, precision, and connectivity in operating rooms and cath labs. Here’s a look at the latest developments from some of Stereotaxis’ key peers:
Intuitive Surgical (ISRG - Free Report) has advanced its innovation roadmap with the rollout of new software features for the da Vinci 5 platform, including real-time visualization and enhanced force feedback for surgeons. ISRG also expanded its Ion endoluminal platform by integrating advanced imaging and AI tools to improve accuracy in minimally invasive lung procedures. These updates reinforce ISRG’s position as a technology leader in robotic-assisted surgery.
In addition, ISRG recently secured CE Mark approval for the da Vinci 5 system in Europe, enabling a broader international rollout. Intuitive Surgical also gained FDA clearance for its Vessel Sealer Curved instrument, further expanding its instrument lineup. With more than 300 new da Vinci system placements reported in recent quarters, ISRG continues to scale its footprint and strengthen its recurring revenue base.
Microbot Medical (MBOT - Free Report) achieved a key milestone with FDA clearance for its LIBERTY Endovascular Robotic System, the first single-use, remotely operated platform cleared for peripheral vascular use. MBOT plans a limited market launch in the fourth quarter of 2025, showcasing the system at the upcoming Symposium on Clinical Interventional Oncology. This debut underscores MBOT’s move from development to commercialization in the endovascular robotics market.
To support its commercial rollout, MBOT has partnered with a U.S.-based logistics provider for inventory and distribution management. MBOT also continues to strengthen its intellectual property portfolio, having recently secured a new patent for a modular robotic surgical system. These developments place MBOT in a stronger position to compete within the growing landscape of robotic-assisted vascular interventions.
PROCEPT BioRobotics (PRCT - Free Report) continues to gain traction with its Aquablation therapy for the treatment of benign prostatic hyperplasia (BPH). In 2025, PRCT achieved a major regulatory milestone with a new Category I CPT code for Aquablation, replacing its previous Category III designation and improving reimbursement prospects. PRCT’s systems are now seeing wider adoption across U.S. hospitals and ambulatory surgical centers.
In its latest update, PRCT reported strong revenue growth, placing 51 new systems in the second quarter of 2025 while expanding gross margins to 65 %. PRCT is also conducting the WATER IV trial to explore Aquablation’s use in prostate cancer within ambulatory surgery settings. With rising clinical validation and growing procedural volume, PRCT remains well-positioned to scale its robotic urology platform.