SS Innovations International, Inc. has announced that it is beginning the process of applying for FDA and CE regulatory approval for its flagship surgical robotic device, the SSi Mantra. The Company has retained Elexes, a regulatory and quality compliance firm, to support the Company as it moves through the approval process.
The SSi Mantra is the first surgical system to be made in India, and one of the only systems in the world to be distinctly cost-effective with broad-spectrum surgical applications, including cardiac surgery. The device has been granted regulatory approval by the Indian Central Drugs Standard Control Organization (CDSCO) and is clinically validated in India in more than 40 different surgical procedures.
Elexes is a regulatory and quality compliance firm with a reputation for delivering excellent expert guidance and unbiased assistance. The company offers services worldwide and assists its clients in securing approvals for breakthrough innovations. Elexes has strong expertise in approval and post market compliance of medical devices, pharmaceutical drugs, and biologics.
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Dr. Sudhir Srivastava, CEO, Chairman and Founder of SS Innovations, said, “As SS Innovations prepares to pursue regulatory approvals for our SSi Mantra surgical robotic device in Europe and the United States, we are very pleased to have retained Elexes to facilitate the process.
“Elexes has an excellent reputation and track record of success, and has previously worked with some of the foundational companies in the medical robotic field, including its key personnel’s experience with Intuitive Surgical and Stryker. We feel confident in the organization’s ability to guide us to achieving FDA and CE approvals in 2024 and 2025.”
