India’s First CDSCO Certified Robotic System for Telesurgery: SSi Mantra Leads the Way
SS Innovations International (OTC: SSII) has achieved a significant milestone by becoming the first company in India to receive CDSCO regulatory approval for Telesurgery and Teleproctoring capabilities of its SSi Mantra surgical robotic system. This breakthrough enables remote surgical procedures and training, particularly benefiting patients in rural areas with access to specialized medical care.
The SSi Mantra system features advanced capabilities including 3-5 robotic arms, a 3D 4K monitor, and over 40 different types of robotic endo-surgical instruments. The system has been clinically validated in India across more than 80 different surgical procedures. The company is currently seeking FDA and CE Mark approvals, anticipated in the second half of 2025.
SS Innovations International (OTC: SSII) ha raggiunto un traguardo significativo diventando la prima azienda in India a ricevere l'approvazione regolatoria CDSCO per le capacità di Telesurgery e Teleproctoring del suo SSi Mantra surgical robotic system. Questa innovazione consente procedure chirurgiche e formazione a distanza, beneficiando in particolare i pazienti nelle aree rurali che hanno accesso a cure mediche specializzate.
Il sistema SSi Mantra presenta capacità avanzate, inclusi da 3 a 5 bracci robotici, un monitor 3D 4K e oltre 40 diversi tipi di strumenti chirurgici endoscopici robotici. Il sistema è stato clinicamente convalidato in India per più di 80 diverse procedure chirurgiche. L'azienda sta attualmente cercando le approvazioni FDA e CE Mark, previste per la seconda metà del 2025.
SS Innovations International (OTC: SSII) ha alcanzado un hito significativo al convertirse en la primera empresa en India en recibir la aprobación regulatoria de CDSCO para las capacidades de Telesurgery y Teleproctoring de su SSi Mantra surgical robotic system. Este avance permite realizar procedimientos quirúrgicos y capacitación a distancia, beneficiando particularmente a los pacientes en áreas rurales con acceso a atención médica especializada.
El sistema SSi Mantra cuenta con capacidades avanzadas que incluyen de 3 a 5 brazos robóticos, un monitor 3D 4K y más de 40 tipos diferentes de instrumentos quirúrgicos endoscópicos robóticos. El sistema ha sido validado clínicamente en India en más de 80 procedimientos quirúrgicos diferentes. La empresa está actualmente buscando aprobaciones de la FDA y del Marcado CE, que se anticipan para la segunda mitad de 2025.
SS Innovations International (OTC: SSII)는 인도에서 SSi Mantra surgical robotic system의 원격 수술 및 원격 교육 능력에 대한 CDSCO 규제 승인을 받은 첫 번째 회사라는 중요한 이정표를 세웠습니다. 이 혁신은 전문 의료 서비스에 대한 접근이 제한된 농촌 지역의 환자들에게 원격 수술 절차와 교육을 가능하게 합니다.
SSi Mantra 시스템은 3-5개의 로봇 팔, 3D 4K 모니터 및 40종 이상의 다양한 로봇 내시경 수술 도구를 포함한 첨단 기능을 제공합니다. 이 시스템은 인도에서 80개 이상의 다양한 수술 절차에 대해 임상적으로 검증되었습니다. 현재 회사는 2025년 하반기에 예상되는 FDA 및 CE 마크 승인을 요청하고 있습니다.
SS Innovations International (OTC: SSII) a atteint une étape significative en devenant la première entreprise en Inde à obtenir l'approbation réglementaire de la CDSCO pour les capacités de Telesurgery et de Teleproctoring de son SSi Mantra surgical robotic system. Cette avancée permet de réaliser des procédures chirurgicales à distance et des formations, profitant particulièrement aux patients dans les zones rurales ayant accès à des soins médicaux spécialisés.
Le système SSi Mantra présente des capacités avancées comprenant 3 à 5 bras robotiques, un moniteur 3D 4K et plus de 40 types différents d'instruments chirurgicaux endoscopiques robotiques. Ce système a été cliniquement validé en Inde pour plus de 80 types de procédures chirurgicales. L'entreprise recherche actuellement des approbations de la FDA et du Marquage CE, attendues pour la deuxième moitié de 2025.
SS Innovations International (OTC: SSII) hat einen bedeutenden Meilenstein erreicht, indem sie das erste Unternehmen in Indien wurde, das die CDSCO-Regulierungszulassung für die Telesurgery- und Teleproctoring-Fähigkeiten ihres SSi Mantra chirurgischen Robotersystems erhielt. Diese Neuerung ermöglicht entfernte chirurgische Eingriffe und Schulungen, was insbesondere Patienten in ländlichen Gebieten zugutekommt, die Zugang zu spezialisierter medizinischer Versorgung haben.
Das SSi Mantra-System verfügt über fortschrittliche Funktionen, darunter 3-5 Roboterarme, einen 3D 4K Monitor und über 40 verschiedene Arten von robotergestützten endoskopischen chirurgischen Instrumenten. Das System wurde klinisch in Indien in mehr als 80 verschiedenen chirurgischen Eingriffen validiert. Das Unternehmen strebt derzeit FDA- und CE-Mark Genehmigungen an, die für die zweite Hälfte des Jahres 2025 erwartet werden.
- First company in India to receive CDSCO approval for Telesurgery capabilities
- System validated in over 80 different surgical procedures
- FDA and CE Mark approvals expected in H2 2025
- Extensive feature set including 3-5 robotic arms and 40+ surgical instruments
- Pending regulatory approvals in major markets (US and EU)
- current market reach (India only)
- SS Innovations becomes the first and only company in India to receive regulatory approval for Telesurgery and Teleproctoring capabilities of a surgical robotic system, its SSi Mantra, marking a significant achievement in surgical robotics
- SS Innovations reinforces India's position as a hub for technological innovation in healthcare using the SSi Mantra - Made in India, for the World
- The SSi Mantra integrates innovative advancements in robotic surgery, offering surgeons enhanced precision and control for improved patient outcome
FORT LAUDERDALE, Fla., Dec. 10, 2024 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (OTC: SSII) (“SS Innovations” or the “Company”), a developer of innovative surgical robotic technologies dedicated to making world-class robotic surgery affordable for and accessible to a global population, has achieved a milestone in Indian medical science by becoming the first and only company in India to receive Central Drugs Standard Control Organization (CDSCO) regulatory approval for Telesurgery and Teleproctoring capabilities of a surgical robotic system, its SSi Mantra, signifying a significant achievement in surgical robotics. The CDSCO is India’s equivalent to the United States Food and Drug Administration (FDA).
This achievement positions the SSi Mantra as the first surgical robotic system in India authorized to perform surgical procedures using these advanced capabilities. It paves the way for SS Innovations' commitment to advancing robotic surgical technology, making cutting-edge procedures more accessible, and reinforcing the position of India as a leader in healthcare innovation.
Telesurgery, first envisioned in the 1980s for use in space and on remote battlefields, faced significant challenges due to the technological limitations and lack of bandwidth available at the time. Today, with advancements in both technology and connectivity, SS Innovations has turned this vision into reality with its innovative SSi Mantra Surgical Robotic System. By integrating Telesurgery and Teleproctoring capabilities, the SSi Mantra aims to decentralize and democratize access to robotic surgical expertise, addressing critical gaps in healthcare, particularly in remote areas, where access to specialized medical care has often been a challenge.
Celebrating this achievement, SS Innovations Founder, Chairman, and CEO, Dr. Sudhir Srivastava, said, “Reaching this milestone with the SSi Mantra is a testament to our vision of transforming surgical practices, enhancing access, and driving the adoption of robotic surgery. Telesurgery and Teleproctoring have been a dream in the making for over four decades, and today, it has finally come to life. With the technology and bandwidth available now, we can truly decentralize and democratize surgical expertise, reaching patients and surgeons in the most remote parts of India and the world. We believe that this innovation is a game-changer, especially for our country, where much of the population lives in smaller towns and rural areas. By enabling remote surgical treatment, we are reshaping the future of healthcare.”
This achievement marks a significant step forward in India’s healthcare landscape, with SS Innovations at the forefront of revolutionizing surgical care through state of the art technology. The approval of Telesurgery and Teleproctoring capabilities for the SSi Mantra not only underscores the Company’s commitment to innovation but also opens up new possibilities for accessible, high-quality healthcare across India and beyond. As SS Innovations continues to expand the boundaries of medical technology, it remains dedicated to transforming healthcare delivery, making advanced treatments more accessible and more economical, thereby improving the lives of patients worldwide.
About SS Innovations:
SS Innovations International, Inc. (OTC: SSII) is a developer of innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger part of the global population. SSII’s product range includes its proprietary “SSi Mantra” surgical robotic system, and “SSi Mudra” its wide range of surgical instruments capable of supporting a variety of surgical procedures including robotic cardiac surgery. SS Innovations’ business operations are headquartered in India and the Company plans to expand the presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions, globally. For more information, visit our website at ssinnovations.com or LinkedIn for updates.
About SSi Mantra:
The SSi Mantra Surgical Robotic System, by SS Innovations, is a modular multi-arm system with many advanced technology features. It allows for the use of 3-5 robotic arms, has an open-faced ergonomic Surgeon Command Centre, 32-inch large 3D 4K monitor, a 23-inch 2D Touch panel monitor for all patient related information display, a virtual real-time image of the robotic Patient Side Arm Carts, and the ability for superimposition of 3D models of diagnostic imaging. The Vision Cart gives the table-side team the same magnified 3D 4K view as the Surgeon to provide better safety and efficiency. The modular robotic arms give flexibility in positioning and the number of arms to be used. This allows for collision-free conduct of surgical operations. There are over 40 different types of robotic endo-surgical instruments that can be used for different specialties including cardiac surgery. The learning curve for surgeons is shorter due to the SSi Mantra’s ergonomic design and user-friendly features.
The SSi Mantra has been clinically validated in India in more than 80 different types of surgical procedures. SS Innovations has commenced the regulatory approval process in the United States and the European Union and anticipates receiving FDA approval to market and CE Mark approval in the second half of 2025.
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FAQ
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