$SSII SS Innovations Provides U.S. Regulatory Upda
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Posted On: 10/03/2025 8:45:11 AM
$SSII SS Innovations Provides U.S. Regulatory Update for the SSi Mantra Surgical Robotic System
https://www.globenewswire.com/news-release/20...ystem.html
Company successfully completed a human factors validation study at Johns Hopkins Hospital
Anticipates submitting a 510(k) premarket notification to the FDA in the fourth quarter of 2025
FORT LAUDERDALE, Fla., Oct. 02, 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 successfully completed a human factors validation study for its SSi Mantra surgical robotic system (the “SSi Mantra”) at Johns Hopkins Hospital in September 2025 and anticipates submitting a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for the SSi Mantra for multiple specialty indications in the fourth quarter of 2025.
The completion of the human factors validation study, which is designed to provide essential evidence that the SSi Mantra meets the FDA’s requirements for usability and patient safety, marks a key milestone and will form an important part of the Company’s forthcoming 510(k) submission. The Company has engaged RQM+, a leading MedTech-focused CRO, to assist with the 510(k) submission.
If the FDA determines that the SSi Mantra can be marketed in the United States, the Company believes that such clearance could occur in the first half of 2026 based on standard review timelines, excluding time required by the Company to respond to any additional information requests.
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “Based on discussions with the FDA and our consultants, we pivoted from filing a De Novo request for our SSi Mantra surgical robotic system to pursuing the 510(k) regulatory pathway, which offers potential speed and cost advantages. We have since made excellent progress as highlighted by the recent completion of a human factors validation study conducted at Johns Hopkins Hospital. This study will be an integral part of our 510(k) premarket notification, which we anticipate submitting to the FDA in the fourth quarter of 2025, bringing us closer to our goal of introducing our advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market.”
As of September 30th, 2025, the SSi Mantra cumulative installed base totaled 125 across six countries where the Company’s surgical robotic system has received regulatory approval. To date, 119 hospitals have installed the SSi Mantra and over 6,000 surgical procedures have been performed, including 60 telesurgeries and 310 cardiac procedures.
https://www.globenewswire.com/news-release/20...ystem.html
Company successfully completed a human factors validation study at Johns Hopkins Hospital
Anticipates submitting a 510(k) premarket notification to the FDA in the fourth quarter of 2025
FORT LAUDERDALE, Fla., Oct. 02, 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 successfully completed a human factors validation study for its SSi Mantra surgical robotic system (the “SSi Mantra”) at Johns Hopkins Hospital in September 2025 and anticipates submitting a 510(k) premarket notification to the United States Food and Drug Administration (the “FDA”) for the SSi Mantra for multiple specialty indications in the fourth quarter of 2025.
The completion of the human factors validation study, which is designed to provide essential evidence that the SSi Mantra meets the FDA’s requirements for usability and patient safety, marks a key milestone and will form an important part of the Company’s forthcoming 510(k) submission. The Company has engaged RQM+, a leading MedTech-focused CRO, to assist with the 510(k) submission.
If the FDA determines that the SSi Mantra can be marketed in the United States, the Company believes that such clearance could occur in the first half of 2026 based on standard review timelines, excluding time required by the Company to respond to any additional information requests.
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “Based on discussions with the FDA and our consultants, we pivoted from filing a De Novo request for our SSi Mantra surgical robotic system to pursuing the 510(k) regulatory pathway, which offers potential speed and cost advantages. We have since made excellent progress as highlighted by the recent completion of a human factors validation study conducted at Johns Hopkins Hospital. This study will be an integral part of our 510(k) premarket notification, which we anticipate submitting to the FDA in the fourth quarter of 2025, bringing us closer to our goal of introducing our advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market.”
As of September 30th, 2025, the SSi Mantra cumulative installed base totaled 125 across six countries where the Company’s surgical robotic system has received regulatory approval. To date, 119 hospitals have installed the SSi Mantra and over 6,000 surgical procedures have been performed, including 60 telesurgeries and 310 cardiac procedures.
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