Stereotaxis(STXS)
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GenesisX Robotic Magnetic Navigation System Receives U.S. FDA Clearance
Globenewswire· 2025-11-10 21:05
Core Insights - Stereotaxis has received FDA 510(k) clearance for its new robotic system, GenesisX, marking a significant advancement in surgical robotics for minimally invasive endovascular interventions [1][3] Product Features - GenesisX enhances Robotic Magnetic Navigation technology, featuring a compact design with magnetic shielding integrated into its structure, allowing for installation in existing cath labs without extensive modifications [2] - The system operates on standard 120/230V power, requires no structural anchoring, and has an 80% smaller system cabinet, improving workflow efficiency while maintaining high standards of speed and responsiveness [2] Market Impact - The approval of GenesisX is expected to broaden the adoption of robotic technology in endovascular surgery, addressing previous infrastructure challenges that limited its use among physicians [3] - Stereotaxis has initiated a limited launch of GenesisX in the U.S. and Europe, while expanding its portfolio of compatible catheters and enhancing various operational processes for a full launch [3] Company Overview - Stereotaxis is a leader in surgical robotics, focusing on the development of innovative systems for minimally invasive interventions, with a mission to improve patient care and operational efficiency in interventional laboratories [4] - The company's technology has been utilized to treat over 150,000 patients globally, demonstrating its impact and reach in the healthcare sector [4]
Stereotaxis to Report Third Quarter 2025 Financial Results on November 11, 2025
Globenewswire· 2025-10-21 13:00
Core Insights - Stereotaxis will release its financial results for the third quarter of 2025 on November 11, 2025, after the U.S. financial markets close [1] - A conference call and webcast will be held on the same day at 4:30 p.m. ET to discuss the results and corporate developments [1][2] Company Overview - Stereotaxis is a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention [3] - The company's mission focuses on the discovery, development, and delivery of robotic systems, instruments, and information solutions for interventional laboratories [3] - Stereotaxis technology has been utilized to treat over 150,000 patients globally, including in the United States, Europe, and Asia [3]
Stereotaxis Rolls Out Synchrony System in EU and Files for FDA Approval
ZACKS· 2025-10-20 14:21
Core Insights - Stereotaxis (STXS) has launched its Synchrony system in Europe and submitted a 510(k) application to the U.S. FDA, aiming to modernize interventional cath labs with a unified digital interface [1][5] - The Synchrony system enhances workflow, visualization, and connectivity, positioning Stereotaxis to expand its market presence in both robotic and non-robotic cath labs [2][4] Product Features - Synchrony features a 55-inch ultra-high-definition 4K display that integrates multiple system feeds into a single interface, providing near-zero latency video streams and customizable layouts [3] - The system is paired with SynX, a secure cloud-based application that enables remote connectivity, collaboration, and real-time monitoring, compliant with HIPAA and GDPR standards [3][4] Strategic Vision - Synchrony and SynX are foundational platforms designed to support future advancements, including AI-driven automation and long-distance robotic procedures, aligning with Stereotaxis' long-term digital surgery vision [4] - The CE Mark approval allows for commercial rollout in EU markets, while the FDA submission paves the way for potential entry into the U.S. market, enhancing Stereotaxis' geographic reach [5] Competitive Landscape - Stereotaxis competes with key players like Intuitive Surgical (ISRG), which has advanced its da Vinci 5 platform with new software features and gained CE Mark approval for broader international rollout [6][7] - Microbot Medical (MBOT) has achieved FDA clearance for its LIBERTY Endovascular Robotic System, marking a significant milestone in the endovascular robotics market [8][10] - PROCEPT BioRobotics (PRCT) reported strong revenue growth and wider adoption of its Aquablation therapy, indicating a competitive environment in robotic-assisted surgical solutions [11][12]
Stereotaxis Announces EU Launch and 510(k) Submission for Synchrony System to Modernize Interventional Cath Labs
Globenewswire· 2025-10-15 11:32
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].
STXS Partners With CardioFocus to Boost Robotic Pulsed Field Ablation
ZACKS· 2025-10-14 17:55
Core Insights - Stereotaxis (STXS) has partnered with CardioFocus to develop the first robotic Pulsed Field Ablation (PFA) system for treating cardiac arrhythmias, combining robotic precision with advanced PFA technology to enhance clinical use and commercialization [1][6][8] Company Summary - The collaboration is expected to leverage the strengths of both companies, enhancing treatment options in electrophysiology and expanding their presence in the growing cardiac care market [2][4] - Stereotaxis aims to integrate CardioFocus's CE-marked Centauri PFA System into its robotic platform, enhancing its product portfolio and creating new revenue streams in the cardiac ablation market [4][11] - STXS currently has a market capitalization of $279.6 million and reported an earnings surprise of 28.6% in the last quarter [5] Market Trends - The global pulsed field ablation market is projected to grow from an estimated size of $913.1 million in 2024 at a CAGR of 33.1% from 2025 to 2030, driven by the rising prevalence of atrial fibrillation and the adoption of minimally invasive procedures [12]
Stereotaxis & CardioFocus Collaborate to Advance Robotic Pulsed Field Ablation for Cardiac Arrhythmias
Globenewswire· 2025-10-13 11:34
Core Insights - Stereotaxis and CardioFocus have entered a Collaboration Agreement to advance robotic Pulsed Field Ablation (PFA) technology for cardiac arrhythmias [1][2][3] Company Overview - Stereotaxis is a leader in surgical robotics for minimally invasive endovascular interventions, having treated over 150,000 patients globally [5] - CardioFocus specializes in pulsed field ablation treatment for cardiac disorders, particularly atrial fibrillation, and has developed the Centauri PFA System, which has been used on over 9,000 patients in Europe [6] Collaboration Details - The collaboration aims to combine the Centauri PFA System with Stereotaxis' MAGiC robotic cardiac ablation catheter, enhancing the efficiency and safety of cardiac ablation procedures [2][3] - Extensive bench and preclinical testing have shown that the combination of Centauri and MAGiC delivers safe and efficient lesion delivery, including durable lesions in ventricular tissue [3] Clinical and Regulatory Progress - The partnership supports advancing the joint solution to clinical trials, facilitating regulatory compatibility and commercial availability [3] - Both companies anticipate transitioning to first human use and advancing the regulatory process in the coming months [4]
STXS Stock Gains as Erasmus Medical Adopts Its Genesis Robotic System
ZACKS· 2025-09-23 18:16
Core Insights - Stereotaxis (STXS) announced the successful performance of the first procedures in the Netherlands using its Genesis Robotic Magnetic Navigation (RMN) System at Erasmus University Medical Center in Rotterdam [1][9] Company Developments - The adoption of Genesis at a leading European cardiac center indicates increasing clinical confidence in robotic solutions for complex arrhythmias, addressing the needs of tens of millions suffering from these conditions globally [2][10] - The collaboration with Erasmus MC enhances Stereotaxis' credibility and supports the broader adoption of its robotic innovations, which is crucial for expanding access to advanced cardiac treatments [2][10] - The Genesis RMN System is recognized for its speed, precision, and safety, particularly when used with the MAGiC catheter, which improves care for complex arrhythmia patients [8][9] Market Performance - Following the announcement, STXS shares increased by 2.5% at the market close, with a year-to-date gain of 26.3%, outperforming the industry which declined by 11.4% [3] - The current market capitalization of STXS stands at $255.9 million [6] Long-term Outlook - The successful introduction of Genesis at a prominent cardiac center is expected to encourage wider adoption among hospitals, leading to increased recurring revenue from system usage and related products [4] - The Genesis RMN System is designed to be smaller and lighter, enhancing patient accessibility and optimizing workspace in electrophysiology labs, which may reduce infrastructure burdens [11][12] - Regulatory approvals in multiple regions, including the FDA in the U.S. and CE-mark in Europe, support the growing clinical use of Genesis, which is essential for generating data and physician experience to drive further adoption [12]
Erasmus Medical Center Advances Cardiovascular Care with Genesis Robotic System
Globenewswire· 2025-09-22 11:56
Core Insights - Stereotaxis has successfully launched its Genesis Robotic Magnetic Navigation System at Erasmus University Medical Center in Rotterdam, marking a significant advancement in surgical robotics for minimally invasive endovascular interventions [1][2]. Company Overview - Stereotaxis is a pioneer in surgical robotics, focusing on minimally invasive endovascular interventions, with a mission to develop robotic systems and solutions that enhance patient care and operational efficiency in interventional laboratories [3]. Technological Advancements - The Genesis System represents the latest in Robotic Magnetic Navigation technology, which enhances precision and safety in cardiac ablation procedures for treating arrhythmias [2]. - The combination of the Genesis system and the MAGiC Catheter has shown synergistic improvements in robotic magnetic navigation, which is crucial for providing optimal care to arrhythmia patients, including those with complex conditions [2]. Clinical Impact - Erasmus MC has performed over 4,500 procedures using Stereotaxis technology, demonstrating the effectiveness and reliability of robotic magnetic navigation in complex arrhythmia treatments [2]. - Arrhythmias affect tens of millions globally, and untreated cases can lead to severe health risks such as stroke and heart failure, highlighting the importance of advanced treatment options like those offered by Stereotaxis [2].
Stereotaxis At Inflection Point: Why I Choose To HOLD (NYSE:STXS)
Seeking Alpha· 2025-09-22 04:14
Core Insights - Stereotaxis, Inc. (NYSE: STXS) has experienced a strong performance in the stock market, with gains exceeding 40% over the past six months [1] - The company faces challenges with a volatile revenue stream, particularly in its 'Systems' segment [1] Company Performance - The stock has had a good year overall, marked by double-digit gains [1] - The recent performance highlights significant investor interest and market confidence in Stereotaxis [1] Revenue Challenges - The revenue stream from the 'Systems' segment has been described as disturbingly volatile, indicating potential risks in this area [1]
15 Best Robotics Stocks to Buy Under $20
Insider Monkey· 2025-09-20 13:22
Industry Overview - The robotics market, encompassing autonomous vehicles, industrial vision, warehouse automation, and surgical systems, is projected to grow to $260 billion by 2030, driven by advancements in artificial intelligence (AI) [2] - AI is expected to transition from software to real-world applications, leading to rapid growth in key technologies such as collaborative robotics, lidar sensors, and machine vision [2][3] - The current market dynamics indicate a shift in leadership beyond major tech companies, with increased investor interest in alternative growth stories, particularly in robotics [3] Investment Opportunities - There are numerous promising robotics companies trading under $20 per share, presenting affordable entry points for investors [4] - The list of 15 robotics stocks includes companies that combine high innovation levels with attractive pricing, allowing early investors to tap into the next wave of automation [4] Methodology - The selection of the 15 best robotics stocks was based on a review of various stocks and hedge fund sentiment, utilizing data from Insider Monkey's database tracking nearly 1,000 elite hedge funds [6] - The stocks are arranged in ascending order based on the number of hedge funds holding each company [6] Company Highlights - **Nauticus Robotics, Inc. (NASDAQ:KITT)**: Recently tested its Aquanaut Mark 2 underwater vehicle at a record depth of 2,300 meters, demonstrating operational capabilities that could reduce subsea costs for oil and gas clients by 30-40% [9][10][11] - **Arbe Robotics Ltd. (NASDAQ:ARBE)**: Secured an order for its radar system to be used in a recreational boat collision avoidance system, showcasing the versatility of its radar technology beyond automotive applications [12][13][14] - **Stereotaxis, Inc. (NYSE:STXS)**: Announced the successful completion of the first robotic high-density mapping procedure in the U.S. with its MAGiC Sweep™ catheter, enhancing arrhythmia diagnosis and treatment [15][16][17]