Smart Vision, Insightful Heart: Ruixin Medical's SonusGuide Intracardiac Echo Catheter Receives NMPA Approval

12Month16RaysightMed's Disposable Intracardiac Ultrasound CatheterSonusGuideOfficially received approval from the China National Medical Products Administration (NMPA）Approved for Marketing (NMPA Registration Approval20253062587）。

RaysightMedICEThe approval of the product not only solidifies RaysightMed's leading position in the field of cardiovascular functional diagnostics but also...Marks RaysightMed's expansion from coronary functional assessment to the field of electrophysiology and structural heart disease intervention, buildingFinishedIntegrated Solution for Precision Cardiac Interventions。

Technology Leadership: Empowering Precision Interventions with Innovative Imaging

RaysightMed's Recently Approved Disposable Intracardiac Ultrasound CatheterSonusGuide, achieving multiple breakthroughs in control performance, surgical success rate, and other aspects, providing more precise solutions for cardiac interventional surgeries.“Raysight”。

SonusGuideAdoptedCutting-edge6The integrated fusion technology of segmental tubing enables the maximum adjustable bending angle of the bending tube to reach180°Industry-leading levelThe internal ultrasound transducer chip adopts advanced multi-matching layer single-crystal composite materials, providing top-tier imaging performance; the acoustic lens uses a cutting-edge extrusion process, replacing the extreme thinness unattainable by injection molding, reducing ultrasound loss. Notably,SonusGuideCatheters are divided into categories based on outer diameter size.8F、10FTwo models are available for flexible selection based on the patient's individual condition.

RaysightMedICEAnother advantage lies in that RaysightMed achieves it in one go.UseIntracardiac Ultrasound CatheterSonusGuideCompatible with RaysightMed intracardiac echocardiography diagnostic equipmentSonusHubUsed as a set, the two form a completeICESystem.

RaysightMed Intracardiac Ultrasound Diagnostic EquipmentSonusHubEquipped withSDBeam™Software Composite Beam Synthesis,eSRI™Core technologies such as image enhancement optimization have enabledUltrasound imaging depth and image clarity are at the industry's leading level, significantly improving surgical efficiency and success rates., especially suitable for preoperative planning of the left atrial appendage and preoperative guidance of the atrial septum. Not only that,SonusHubCharacterized by flexibility and convenience,ItsEquipped witheTunerOne-click adaptive gain parameter setting eliminates the need for frequent manual adjustments. It can also flexibly integrate with carts, supporting both portable and upright modes, making it suitable for various scenarios such as catheterization labs.

Strategic Upgrade:

Building an Integrated Solution for Precision Cardiac Interventions

RaysightMedICEThe advantage of the system lies in integration.ICE and AITechnology, UtilizationAIAutomatically identify various cardiac structures within the ultrasound fan area, as well as useAICombined HeartCT、DSAMultimodal images for preoperative planning and intraoperative navigation of electrophysiological and structural heart surgeries, assisting doctors in completing surgeries more safely and efficiently.Currently，R&D TeamCompletedICE AIThe algorithm framework brings breakthrough progress to the entire field.

This timeICEThe approval of the product is not just the launch of a single product, but a crucial step in the extension of RaysightMed's core capabilities into new fields. Relying onAI, Robot,3DWith technical accumulation in fields such as simulation and connected sensor chips, RaysightMed has built"System+Equipment+Consumables"The complete electrophysiology and structural heart solution. Combined with the previously launchedCT-FFRProductRaysightMed Score（RuiXin-FFR）、Contrast ImagingFFRProductRaysightMedAngio QFA, as well as the fully automatic under researchAIVascular Interventional Surgical Robot,The company has built an integrated solution for precise cardiac intervention that covers the fields of coronary, structural heart disease, and electrophysiology, spanning preoperative diagnosis, intraoperative navigation and intelligent treatment, and postoperative health management.。

Clinical Validation: Outstanding Performance Recognized by Authoritative Experts

This Year8Month, RaysightMed Disposable Intracardiac Ultrasound CatheterSonusGuideAnd Intracardiac Ultrasound Diagnostic EquipmentSonusHubThe pre-market clinical trial was officially completed at the First Affiliated Hospital of Jinan University.Research data shows that the clinical excellent rate and surgical success rate of this product have both reached100%, with outstanding performance.

The clinical research project is led by Professor Guo Jun from the Cardiology Department of the First Affiliated Hospital of Jinan University. He stated:“Intracardiac echocardiography has the advantages of real-time imaging, real-time monitoring of intraoperative complications, and good tolerance. In recent years, it has been increasingly used in various types of cardiac interventional procedures. RaysightMed Intracardiac Echocardiography Diagnostic DeviceSonusHubAnd disposable intracardiac echocardiography cathetersSonusGuideTheThe imaging depth and image clarity are among the best in the industry, which is expected to increase the success rate of interventional surgeries and avoid or reduce complications.`, looking forward to its early application in clinical settings to benefit more patients.`”

Professor Xianwu Lan from the Department of Cardiology at the First Affiliated Hospital of Jinan University commented: "SonusGuideCatheterExcellent imaging quality, outstanding bending performance, Combined withSonusHubThe host can effectively improve the safety of the surgery.The concept of green electrophysiology not only reduces radiation exposure for both medical staff and patients but also helps alleviate patient suffering while controlling medical costs, making the diagnosis and treatment of complex heart diseases more precise, safe, and efficient.”

This approval marks an important milestone for RaysightMed on its path of innovation.Next,The company will continue to focus on the heartZangIn the field of precision intervention, join hands with global clinical experts and industry partners to jointly lead“Precision, Intelligence, Integration”The HeartInterventionA New Era of Diagnosis and Treatment.

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