SS Innovations International's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by SS Innovations International (SSII).
Over the past two years, SS Innovations International has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
SSi. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
SSi Mantra surgical robotic system FDA Regulatory Events
SSi Mantra surgical robotic system is a drug developed by SS Innovations International for the following indication: robotic surgery.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- SSi Mantra surgical robotic system
- Announced Date:
- October 2, 2025
- Estimated Event Date Range:
- October 1, 2025 - December 31, 2025
- Target Action Date:
- Q4 2025
- Indication:
- robotic surgery
Announcement
SS Innovations International 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.
AI Summary
In September 2025, SS Innovations completed a human factors validation study at Johns Hopkins Hospital for its SSi Mantra robotic system. This study provides essential evidence that the system meets FDA requirements for usability and patient safety, and it will be a key part of the company’s upcoming regulatory filing.
SS Innovations anticipates submitting a 510(k) premarket notification to the U.S. Food and Drug Administration in the fourth quarter of 2025. The company has engaged RQM+, a specialized medical technology contract research organization, to support the submission process. Based on standard review timelines, and excluding any additional information requests, FDA clearance could be granted in the first half of 2026.
If cleared, the SSi Mantra could soon be marketed in the United States, advancing SS Innovations’ mission to make advanced, cost-efficient surgical robotics more accessible to hospitals and patients nationwide.
Read Announcement- Drug:
- SSi Mantra surgical robotic system
- Announced Date:
- October 2, 2025
- Indication:
- robotic surgery
Announcement
SS Innovations International 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
AI Summary
In September 2025, SS Innovations International successfully completed a human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital. The study proved that the system meets key FDA requirements for usability and patient safety, marking a significant step toward U.S. regulatory approval.
Building on this milestone, the company plans to submit a 510(k) premarket notification to the FDA in the fourth quarter of 2025. SS Innovations has partnered with RQM+, a leading MedTech-focused CRO, to guide the submission process. If the FDA agrees that SSi Mantra can be marketed, clearance could follow in the first half of 2026 under standard review timelines.
SS Innovations designs user-friendly robotic surgery solutions for hospitals. The SSi Mantra system has been installed in several countries, supporting thousands of procedures and aiming to make advanced robotic surgery more accessible.
Read Announcement
SS Innovations International FDA Events - Frequently Asked Questions
As of now, SS Innovations International (SSII) has not received any FDA approvals for its therapy in the last two years.
In the past two years, SS Innovations International (SSII) has reported FDA regulatory activity for SSi Mantra surgical robotic system.
The most recent FDA-related event for SS Innovations International occurred on October 2, 2025, involving SSi Mantra surgical robotic system. The update was categorized as "Pre-Marketing Filing," with the company reporting: "SS Innovations International 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."
Currently, SS Innovations International has one therapy (SSi Mantra surgical robotic system) targeting the following condition: robotic surgery.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:SSII) was last updated on 10/23/2025 by MarketBeat.com Staff
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