SS Innovations Submits Response to FDA Request for Additional Information Regarding the Company’s 510(k) Submission for the SSi Mantra

The submission covers gallbladder removal and now includes final data from expanded clinical validation and bridging studies.

Rhea-AI Summary

SS Innovations International (SSII) submitted its response to an FDA request for additional information on SSi Mantra on October 5, 2026. The response concerns the surgical robotic system’s 510(k) premarket notification, a submission seeking FDA clearance, for an initial indication of cholecystectomy, or gallbladder removal.

The response includes final data from a completed, expanded human clinical and human factors validation study, designed to provide evidence addressing FDA safety, efficacy and feasibility requirements. It also includes final data from a bridging study completed in August 2026 at Hospital Internacional de Colombia in Bucaramanga, Colombia. SS Innovations expects the FDA to complete its review of the response and submission in the first quarter of 2027; that timing is an expectation, not a completed clearance.

3 points · 0 major

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0 major · 1 point

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate pointSSi Mantra’s FDA submission advanced with the additional-information response submitted on October 5, 2026.
• Minor pointThe completed expanded human clinical and human factors validation study supplied final data for the response.
• Minor pointThe bridging study completed in August 2026 in Colombia also supplied final data.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.FDA review remains pending; SS Innovations expects completion in the first quarter of 2027.

Key Figures

Response submitted: October 5, 2026 Expected FDA review completion: Q1 2027

Response submitted

October 5, 2026

Response to the FDA's request for additional information

Expected FDA review completion

Q1 2027

Review of the response and the SSi Mantra 510(k) submission

Historical Context

1 past event · Latest: Sep 10

1 event

1. Sep 10

   FDA review update

   24h Move

   +2.5%

   Earlier update cited expected FDA review completion by the end of Q1 2027.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

510(k), human factors validation study, bridging study, cholecystectomy

4 terms

510(k) regulatory

"510(k) submission for its SSi Mantra surgical robotic system"

A 510(k) is a U.S. regulatory submission that a medical device maker uses to show a new device is as safe and effective as an already-approved device, allowing the regulator to clear it for sale rather than requiring the longer, more stringent approval process. For investors, a cleared 510(k) usually means lower regulatory risk and a faster path to market, which can speed revenue generation and reduce uncertainty—similar to proving a new appliance works like a trusted existing model.

human factors validation study medical

"final data from an expanded human clinical and human factors validation study"

A human factors validation study tests whether real people can use a medical device, diagnostic tool, or related product safely and effectively when following its instructions, like a final dress rehearsal where users perform typical tasks under realistic conditions. For investors, the study matters because passing it is often required by regulators and reduces the risk of user errors, delays, costly redesigns, or product recalls, so it strengthens the product’s chances of timely market approval and commercial success.

bridging study medical

"final data from a bridging study"

A bridging study is a clinical or pharmacokinetic study run to determine whether data from trials conducted in one population, formulation, or region can be applied to a different population, formulation, or regulatory jurisdiction. It typically measures key variables—such as drug exposure, safety signals, or short-term efficacy endpoints—needed by regulators to ‘bridge’ foreign or earlier trial results to the new setting; bridging studies are usually smaller and more targeted than full pivotal trials and do not automatically substitute for a full local approval study if regulators require additional evidence.

cholecystectomy medical

"initial indication of cholecystectomy (gallbladder removal)"

Cholecystectomy is the surgical removal of the gallbladder, an organ that stores bile used for digestion; surgeons often remove it through a few small incisions using minimally invasive techniques. For investors, procedure volumes and trends matter because they drive revenue for hospitals, surgical device makers, imaging suppliers and insurers—similar to how demand for car repairs affects parts manufacturers and garages. Shifts in how often or how the surgery is done can signal changes in healthcare spending and technology adoption.

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FORT LAUDERDALE, Fla., Oct. 13, 2026 (GLOBE NEWSWIRE) -- via IBN -- 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, on October 5, 2026, the Company submitted its response to a request for additional information letter (the “AINN”) received from the United States Food and Drug Administration (the “FDA”) with regard to the Company’s 510(k) submission for its SSi Mantra surgical robotic system (the “SSi Mantra”). 

The Company’s response to the AINN includes final data from an expanded human clinical and human factors validation study (the “Study”) for the SSi Mantra.  The completion of the Study was designed to provide essential evidence that the SSi Mantra meets the FDA’s requirements for safety, efficacy and feasibility, and is an important part of the Company’s 510(k) premarket notification.

The Company’s response to the AINN also includes final data from a bridging study (the “Bridging Study”), which the Company completed in August 2026 at Hospital Internacional de Colombia, a member of the Mayo Clinic Care Network located in Bucaramanga, Colombia.

The Company anticipates that the FDA will complete its review of the Company’s AINN response and the Company’s 510(k) submission for the SSi Mantra in the first quarter of 2027.     

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).

Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “In response to the FDA’s request for additional information, we completed an expanded human clinical and human factors validation study for our SSi Mantra surgical robotic system.   Our response to the FDA’s AINN brings us closer to our goal of introducing our advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market.”

About SS Innovations
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’s product range includes its proprietary “SSi Mantra” surgical robotic system and its comprehensive suite of “SSi Mudra” surgical instruments, which support a variety of surgical robotic procedures including cardiac surgery.  Headquartered 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.  Visit the Company’s website at ssinnovations.com or LinkedIn for more information and updates.

About the SSi Mantra
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’s 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.

Forward Looking Statements
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 “anticipate,” “assume,” “believe,” “estimate,” “expect,” “will,” “intend,” “may,” “plan,” “project,” “should,” “could,” “seek,” “designed,” “potential,” “forecast,” “target,” “objective,” “goal,” 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’ 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.

Investor Contact:
The Equity Group       
Kalle Ahl, CFA             
T: (303) 953-9878       
kalle.ahl@theequitygroup.com

Devin Sullivan, Managing Director
T: (212) 836-9608
devin.sullivan@theequitygroup.com

Media Contact:
RooneyPartners LLC
Kate Barrette
T: (212) 223-0561
kbarrette@rooneypartners.com

Corporate Communications:

IBN
Austin, Texas
IBN.Ai
512.354.7000 Office
Editor@IBN.Ai

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

When does SS Innovations expect the FDA to finish reviewing the SSi Mantra submission?

SS Innovations expects the FDA to complete its review of the additional-information response and SSi Mantra’s 510(k) submission in the first quarter of 2027. This is an expected review timeline, not an announced clearance.

Who assisted SS Innovations with the SSi Mantra FDA submission and studies?

Daniel & Daniel Consulting was engaged to assist with the additional-information response, the expanded human clinical and human factors validation study, the bridging study and the 510(k) submission.