SS Innovations Advances Robotics Surgery with New FDA Submission

SS Innovations Makes Progress in Surgical Robotics

Innovations in surgical robotics are paving the way for enhanced patient care, and SS Innovations International, Inc. is at the forefront of this revolution. The company recently achieved a significant milestone by successfully concluding a human factors validation study for its SSi Mantra surgical robotic system. This study took place at the prestigious Johns Hopkins Hospital, marking a crucial step towards gaining approval from the FDA.

Successful Completion of Human Factors Validation

The human factors validation study is pivotal as it provides necessary evidence of the SSi Mantra's usability and patient safety, key factors in meeting the FDA's regulatory standards. With plans to submit a 510(k) premarket notification to the FDA, SS Innovations is anticipating this submission in the coming months. RQM+, a renowned MedTech-focused contract research organization, has been engaged to assist in this vital process, ensuring that all components of the submission are robust and comprehensive.

Potential FDA Clearance Timeline

The timeline for FDA clearance is a crucial aspect for any company involved in medical technology. SS Innovations believes that if their SSi Mantra qualifies for marketing approval, this could be achieved by mid-2026, adhering to the standard review timelines set by the FDA. This timeline, however, will depend on the time required for the company to address any additional information requests from the FDA.

CEO Insights and Strategic Directions

Dr. Sudhir Srivastava, the Chairman of the Board and CEO of SS Innovations, shared insights regarding their strategic decision to pursue the 510(k) pathway instead of a De Novo request. This strategic pivot emphasizes speed and cost-effectiveness, providing a pathway that could facilitate a quicker introduction of their advanced SSi Mantra surgical robotic system into the U.S. market. Dr. Srivastava’s comments highlight the forward momentum of the company's objectives and the importance of the completed validation study in advancing their regulatory pursuits.

Growing Installed Base and Surgical Procedures

As of the latest updates, the company has established a cumulative installed base of 125 SSi Mantra systems across six countries with regulatory approvals. This impressive figure reflects the growing acceptance of their technology in the surgical field. Over 119 hospitals are currently utilizing the SSi Mantra, with more than 6,000 procedures performed to date, including innovative telesurgeries and critical cardiac surgeries. These statistics underline the system's effectiveness and versatility in a variety of surgical settings.

About SS Innovations and Its Technological Vision

SS Innovations is dedicated to making robotic surgery accessible and affordable to a broader segment of the global population. Their flagship product, the SSi Mantra surgical robotic system, exemplifies this mission. It features a user-friendly, modular design that incorporates advanced technology like modular robotic arms and a state-of-the-art ergonomic surgeon command center. Capable of performing various types of surgical procedures, the SSi Mantra ensures safety and efficiency with its comprehensive design. The company aims to expand its global reach, ensuring that these advanced solutions are available to surgeons and patients worldwide.

Surgical Instrumentation and Specialties

Alongside the SSi Mantra, the company also provides a full suite of “SSi Mudra” surgical instruments. These instruments are meticulously designed to support a range of medical specialties, including robotic cardiac surgery. The versatility of the SSi Mantra, combined with its array of innovative instruments, positions SS Innovations as a formidable player in the field of surgical robotics.

Frequently Asked Questions

What is the SSi Mantra surgical robotic system?

The SSi Mantra is a modular, multi-arm robotic surgical system designed to enhance surgical procedures with advanced technology and user-friendly interfaces.

When does SS Innovations plan to submit the 510(k) notification?

SS Innovations anticipates submitting the 510(k) premarket notification to the FDA in the fourth quarter of 2025.

What are the advantages of the 510(k) pathway?

The 510(k) pathway offers potential cost and time efficiencies compared to other regulatory options, facilitating quicker access to market approval.

How many procedures has the SSi Mantra successfully completed?

To date, over 6,000 surgical procedures have been performed using the SSi Mantra, showcasing its effectiveness in various surgical scenarios.

What is the company’s vision for surgical robotics?

SS Innovations aims to make robotic surgery more affordable and accessible to a larger population globally, enhancing healthcare delivery through innovative technology.

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