SS Innovations International (SSII) FDA Approvals $3.90 -0.15 (-3.70%) Closing price 04:00 PM EasternExtended Trading$3.93 +0.03 (+0.77%) As of 07:12 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsEarningsFDA EventsFinancialsHeadlinesInsider TradesOwnershipSEC FilingsShort InterestTrendsBuy This Stock SS Innovations International's Drug in the FDA Approval ProcessThis 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. Pre-Marketing Filing - October 2,2025Pre-Marketing Filing Drug: SSi Mantra surgical robotic systemAnnounced Date: October 2, 2025Target Action Date: Q4 2025Estimated Target Date Range: October 1, 2025 - December 31, 2025Indication: robotic surgeryAnnouncementSS 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 SummaryIn 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 AnnouncementProvided Update - October 2,2025Provided Update Drug: SSi Mantra surgical robotic systemAnnounced Date: October 2, 2025Indication: robotic surgeryAnnouncementSS 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 2025AI SummaryIn 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 Has SS Innovations International received FDA approval? As of now, SS Innovations International (SSII) has not received any FDA approvals for its therapy in the last two years. What drugs has SS Innovations International submitted to the FDA? In the past two years, SS Innovations International (SSII) has reported FDA regulatory activity for SSi Mantra surgical robotic system. What is the most recent FDA event for SS Innovations International? 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 "Provided Update," with the company reporting: "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" What conditions do SS Innovations International's current drugs treat? 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 Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events Allarity Therapeutics FDA EventsAvalo Therapeutics FDA EventsBridgeBio Pharma FDA EventsCellectar Biosciences FDA EventsCytokinetics FDA EventsEupraxia Pharmaceuticals FDA EventsFate Therapeutics FDA EventsHoth Therapeutics FDA EventsKymera Therapeutics FDA EventsPalisade Bio FDA EventsRelmada Therapeutics FDA EventsSensei Biotherapeutics FDA EventsVerrica Pharmaceuticals FDA EventsViridian Therapeutics FDA EventsZentalis Pharmaceuticals FDA Events 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 Related Companies Soleno Therapeutics FDA Events AxoGen FDA Events NovoCure FDA Events Artivion FDA Events Inspire Medical Systems FDA Events Pulse Biosciences FDA Events PROCEPT BioRobotics FDA Events iRadimed FDA Events Bioventus FDA Events Spyglass Pharma FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NASDAQ:SSII last updated on 10/2/2025 by MarketBeat.com Staff. 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Pre-Marketing Filing - October 2,2025Pre-Marketing Filing Drug: SSi Mantra surgical robotic systemAnnounced Date: October 2, 2025Target Action Date: Q4 2025Estimated Target Date Range: October 1, 2025 - December 31, 2025Indication: robotic surgeryAnnouncementSS 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 SummaryIn 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
Provided Update - October 2,2025Provided Update Drug: SSi Mantra surgical robotic systemAnnounced Date: October 2, 2025Indication: robotic surgeryAnnouncementSS 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 2025AI SummaryIn 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
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