$SSII SS Innovations to Submit De Novo Application
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Posted On: 05/08/2025 10:45:19 AM
$SSII SS Innovations to Submit De Novo Application to the FDA for the SSi Mantra 3 Surgical Robotic System for Multiple Indications
https://www.globenewswire.com/news-release/20...tions.html
FORT LAUDERDALE, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company is planning to submit a De Novo Classification Request to the U.S. Food and Drug Administration (the “FDA”) for the SSi Mantra 3 surgical robotic system (the “SSi Mantra 3”) in July 2025.
If approved by the FDA, the SSi Mantra 3 would be cleared to market in the United States. Submission of the De Novo Classification Request does not guarantee FDA approval.
Since the Company began the sale of its system in August 2022 it has installed a total of 80 SSi Mantra robotic surgical systems in 75 hospitals and over 3,800 surgeries have been performed, including over 200 robotic cardiac surgeries. The SSi Mantra 3 version was launched in June 2024, and the Company has already installed 37 systems that have been utilized to perform more than 750 multispecialty robotic surgical procedures, including 70 cardiac cases, with no device related mortality, injury or complications.
Real world clinical data, validated by a leading contract research organization (“CRO”), supports the ability of the SSi Mantra 3 to safely perform a wide variety of surgical procedures. The planned submission of the SSi Mantra 3 to the FDA will include an application for multispecialty indications including urology, gynecology, general surgery, and thoracic and cardiac surgery.
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “We currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion. We are taking important steps, including the planned De Novo application to the FDA, to introduce our empowering, cost-effective surgical robotic technology to the U.S. market. In parallel, we are pursuing European Union CE Mark approval for our SSi Mantra surgical robotic system and look forward to our future with great confidence.”
https://www.globenewswire.com/news-release/20...tions.html
FORT LAUDERDALE, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (Nasdaq: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that the Company is planning to submit a De Novo Classification Request to the U.S. Food and Drug Administration (the “FDA”) for the SSi Mantra 3 surgical robotic system (the “SSi Mantra 3”) in July 2025.
If approved by the FDA, the SSi Mantra 3 would be cleared to market in the United States. Submission of the De Novo Classification Request does not guarantee FDA approval.
Since the Company began the sale of its system in August 2022 it has installed a total of 80 SSi Mantra robotic surgical systems in 75 hospitals and over 3,800 surgeries have been performed, including over 200 robotic cardiac surgeries. The SSi Mantra 3 version was launched in June 2024, and the Company has already installed 37 systems that have been utilized to perform more than 750 multispecialty robotic surgical procedures, including 70 cardiac cases, with no device related mortality, injury or complications.
Real world clinical data, validated by a leading contract research organization (“CRO”), supports the ability of the SSi Mantra 3 to safely perform a wide variety of surgical procedures. The planned submission of the SSi Mantra 3 to the FDA will include an application for multispecialty indications including urology, gynecology, general surgery, and thoracic and cardiac surgery.
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “We currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion. We are taking important steps, including the planned De Novo application to the FDA, to introduce our empowering, cost-effective surgical robotic technology to the U.S. market. In parallel, we are pursuing European Union CE Mark approval for our SSi Mantra surgical robotic system and look forward to our future with great confidence.”
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