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SS Innovations International (SSII) FDA Approvals

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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.

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

  • 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 10/3/2025 by MarketBeat.com Staff
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