{"id":1009632,"date":"2026-10-13T11:20:28","date_gmt":"2026-10-13T15:20:28","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/ss-innovations-submits-response-to-fda-request-for-additional-information-regarding-the-companys-510k-submission-for-the-ssi-mantra\/"},"modified":"2026-10-13T11:20:28","modified_gmt":"2026-10-13T15:20:28","slug":"ss-innovations-submits-response-to-fda-request-for-additional-information-regarding-the-companys-510k-submission-for-the-ssi-mantra","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/ss-innovations-submits-response-to-fda-request-for-additional-information-regarding-the-companys-510k-submission-for-the-ssi-mantra\/","title":{"rendered":"SS Innovations Submits Response to FDA Request for Additional Information Regarding the Company\u2019s 510(k) Submission for the SSi Mantra"},"content":{"rendered":"
\n

FORT LAUDERDALE, Fla., Oct. 13, 2026 (GLOBE NEWSWIRE) — via IBN — SS Innovations International, Inc.<\/b><\/a>(the \u201cCompany\u201d or \u201cSS Innovations\u201d) (NASDAQ: SSII)<\/b>, a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that, on October 5, 2026, the Company submitted its response to a request for additional information letter (the \u201cAINN<\/b>\u201d) received from the United States Food and Drug Administration (the \u201cFDA<\/b>\u201d) with regard to the Company\u2019s 510(k) submission for its SSi Mantra surgical robotic system (the \u201cSSi Mantra<\/b>\u201d).\u00a0<\/p>\n

The Company\u2019s response to the AINN includes final data from an expanded human clinical and human factors validation study (the \u201cStudy<\/b>\u201d) for the SSi Mantra.\u00a0 The completion of the Study was designed to provide essential evidence that the SSi Mantra meets the FDA\u2019s requirements for safety, efficacy and feasibility, and is an important part of the Company\u2019s 510(k) premarket notification.<\/p>\n

The Company\u2019s response to the AINN also includes final data from a bridging study (the \u201cBridging Study<\/b>\u201d), which the Company completed in August 2026 at Hospital Internacional de Colombia, a member of the Mayo Clinic Care Network located in Bucaramanga, Colombia.<\/p>\n

The Company anticipates that the FDA will complete its review of the Company\u2019s AINN response and the Company\u2019s 510(k) submission for the SSi Mantra in the first quarter of 2027. \u00a0\u00a0\u00a0\u00a0<\/p>\n

The Company engaged Daniel & Daniel Consulting, LLC to assist with the AINN response, the Study, the Bridging Study, and the 510(k) submission, which covers the initial indication of cholecystectomy (gallbladder removal).<\/p>\n

Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, \u201cIn response to the FDA\u2019s request for additional information, we completed an expanded human clinical and human factors validation study for our SSi Mantra surgical robotic system. \u00a0\u00a0Our response to the FDA\u2019s AINN brings us closer to our goal of introducing our advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market.\u201d<\/p>\n

\n About SS Innovations <\/b>
\n
SS Innovations International, Inc. (Nasdaq: SSII) develops innovative surgical robotic technologies with a vision to make the benefits of robotic surgery affordable and accessible to a larger segment of the global population. The Company\u2019s product range includes its proprietary \u201cSSi Mantra\u201d surgical robotic system and its comprehensive suite of \u201cSSi Mudra\u201d surgical instruments, which support a variety of surgical robotic procedures including cardiac surgery. \u00a0Headquartered in India, SS Innovations is a U.S. company focused on expanding the global presence of its technologically advanced, user-friendly, and cost-effective surgical robotic solutions. \u00a0Visit the Company\u2019s website at ssinnovations.com<\/a> or LinkedIn<\/a> for more information and updates.<\/p>\n

\n About the SSi Mantra<\/b>
\n
The SSi Mantra surgical robotic system is a modular, multi-arm system with advanced technology features, including: 3 to 5 modular robotic arms, an open-faced ergonomic surgeon command center, a large 3D 4K monitor, a 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 optional SSi MantrAsana tele-surgeon console is a portable, compact alternative to the SSi Mantra\u2019s standard surgeon command center that is intended to provide equivalent control functionality while enabling enhanced portability, ergonomic flexibility, and telesurgery capability. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery, and 5mm instruments for the pediatric population and ENT surgeries. A vision cart is designed to provide the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra has been clinically validated in India in more than 190 different types of surgical procedures.<\/p>\n

\n Forward Looking Statements<\/b>
\n
This press release may contain statements that are not historical facts and are considered forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words \u201canticipate,\u201d \u201cassume,\u201d \u201cbelieve,\u201d \u201cestimate,\u201d \u201cexpect,\u201d \u201cwill,\u201d \u201cintend,\u201d \u201cmay,\u201d \u201cplan,\u201d \u201cproject,\u201d \u201cshould,\u201d \u201ccould,\u201d \u201cseek,\u201d \u201cdesigned,\u201d \u201cpotential,\u201d \u201cforecast,\u201d \u201ctarget,\u201d \u201cobjective,\u201d \u201cgoal,\u201d or the negatives of such terms or other similar expressions to identify such forward-looking statements. These statements relate to future events or SS Innovations\u2019 future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements.<\/p>\n

\n Investor Contact:<\/b>
\n
The Equity Group\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
Kalle Ahl, CFA\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
T: (303) 953-9878\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0\u00a0
kalle.ahl@theequitygroup.com<\/a><\/p>\n

Devin Sullivan, Managing Director
T: (212) 836-9608
devin.sullivan@theequitygroup.com<\/a><\/p>\n

\n Media Contact:<\/b>
\n
RooneyPartners LLC
Kate Barrette
T: (212) 223-0561
kbarrette@rooneypartners.com<\/a><\/p>\n

\n Corporate Communications:<\/b>\n <\/p>\n

IBN
Austin, Texas
IBN.Ai<\/a>
512.354.7000 Office
Editor@IBN.Ai<\/a><\/p>\n

\"\"
\n
\n \"\"\n <\/div>\n

<\/div>\n","protected":false},"excerpt":{"rendered":"

FORT LAUDERDALE, Fla., Oct. 13, 2026 (GLOBE NEWSWIRE) — via IBN — SS Innovations International, Inc.(the \u201cCompany\u201d or \u201cSS Innovations\u201d) (NASDAQ: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that, on October 5, 2026, the Company submitted its response to a request for additional information letter (the \u201cAINN\u201d) received from the United States Food and Drug Administration (the \u201cFDA\u201d) with regard to the Company\u2019s 510(k) submission for its SSi Mantra surgical robotic system (the \u201cSSi Mantra\u201d).\u00a0 The Company\u2019s response to the AINN includes final data from an expanded human clinical and human factors validation study (the \u201cStudy\u201d) for the SSi Mantra.\u00a0 The completion of the Study … <\/p>\n

Continue reading “SS Innovations Submits Response to FDA Request for Additional Information Regarding the Company\u2019s 510(k) Submission for the SSi Mantra”<\/span><\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[],"tags":[],"class_list":["post-1009632","post","type-post","status-publish","format-standard","hentry"],"yoast_head":"\nSS Innovations Submits Response to FDA Request for Additional Information Regarding the Company\u2019s 510(k) Submission for the SSi Mantra - Market Newsdesk<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.marketnewsdesk.com\/index.php\/ss-innovations-submits-response-to-fda-request-for-additional-information-regarding-the-companys-510k-submission-for-the-ssi-mantra\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"SS Innovations Submits Response to FDA Request for Additional Information Regarding the Company\u2019s 510(k) Submission for the SSi Mantra - 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