SS Innovations Provides U.S. Regulatory Update for the SSi Mantra Surgical Robotic System
SS Innovations International (NASDAQ:SSII) has completed a crucial human factors validation study for its SSi Mantra surgical robotic system at Johns Hopkins Hospital in September 2025. The company plans to submit a 510(k) premarket notification to the FDA in Q4 2025, shifting from its previous De Novo pathway strategy.
The company has partnered with RQM+, a MedTech-focused CRO, for the submission process and anticipates potential FDA clearance in H1 2026. Currently, the SSi Mantra has an installed base of 125 units across 6 countries, with over 6,000 surgical procedures completed, including 60 telesurgeries and 310 cardiac procedures.
SS Innovations International (NASDAQ:SSII) ha completato uno studio di validazione dei fattori umani per il sistema robotico chirurgico SSi Mantra presso il Johns Hopkins Hospital nel settembre 2025. L'azienda prevede di presentare una notifica di preregistrazione 510(k) alla FDA nel Q4 2025, passando dalla precedente strategia De Novo.
L'azienda ha stretto una partnership con RQM+, un CRO focalizzato MedTech, per il processo di sottomissione e prevede una potenziale approvazione FDA nel 2026 nel primo semestre. Attualmente, SSi Mantra ha una base installata di 125 unità in 6 paesi, con più di 6.000 procedure chirurgiche completate, tra cui 60 telesurgerie e 310 procedure cardiache.
SS Innovations International (NASDAQ:SSII) ha completado un crucial estudio de validación de factores humanos para su sistema robótico quirúrgico SSi Mantra en el Johns Hopkins Hospital en septiembre de 2025. La empresa planea presentar una notificación previa de 510(k) a la FDA en el Q4 de 2025, cambiando de su anterior estrategia de vía De Novo.
La compañía se ha asociado con RQM+, un CRO centrado en MedTech, para el proceso de presentación y anticipa una posible aprobación de la FDA en el primer semestre de 2026. Actualmente, SSi Mantra tiene una base instalada de 125 unidades en 6 países, con más de 6.000 intervenciones quirúrgicas realizadas, incluidas 60 telesoperaciones y 310 procedimientos cardíacos.
SS Innovations International (NASDAQ:SSII)은 Johns Hopkins Hospital에서 2025년 9월에 SSi Mantra 수술용 로봇 시스템에 대한 중요한 인간공학적 요인 검증 연구를 완료했습니다. 회사는 2025년 4분기에 FDA에 510(k) 프리마켓 노티피케이션을 제출할 계획이며 이전의 De Novo 경로 전략에서 전환합니다.
회사는 MedTech에 초점을 맞춘 CRO인 RQM+와 제출 과정 파트너십을 맺었으며 2026년 상반기에 FDA 승인을 기대합니다. 현재 SSi Mantra의 설치 대수는 전 세계 6개국에 125대이며 6,000건이 넘는 외과적 시술을 완료했으며 이 중 60건의 텔레외과 수술과 310건의 심장 수술이 포함됩니다.
SS Innovations International (NASDAQ:SSII) a mené à bien une étude cruciale de validation des facteurs humains pour son système robotique chirurgical SSi Mantra à l'hôpital Johns Hopkins en septembre 2025. L'entreprise prévoit de déposer une notification pré-commercialisation 510(k) auprès de la FDA au cours du dernier trimestre de 2025, abandonnant ainsi sa précédente stratégie De Novo.
Elle s'est associée à RQM+, un CRO axé MedTech, pour le processus de soumission et anticipe une éventuelle autorisation par la FDA au premier semestre 2026. Actuellement, le SSi Mantra dispose d'une base installée de 125 unités dans 6 pays, avec plus de 6 000 interventions chirurgicales réalisées, dont 60 téléchirurgies et 310 procédures cardiaques.
SS Innovations International (NASDAQ:SSII) hat eine entscheidende Validierungsstudie zu Mensch-Maschine-Faktoren für das SSi Mantra-Operationsrobotersystem am Johns Hopkins Hospital im September 2025 abgeschlossen. Das Unternehmen plant, im Vierte Quartal 2025 eine 510(k) Premarket-Mitteilung an die FDA zu übermitteln und damit seinen bisherigen De-Novo-Weg zu verlassen.
Das Unternehmen arbeitet mit RQM+ zusammen, einem auf MedTech fokussierten CRO, für den Einreichungsprozess und rechnet mit einer potenziellen FDA-Zulassung im ersten Halbjahr 2026. Derzeit verfügt der SSi Mantra über eine installierte Basis von 125 Einheiten in 6 Ländern, mit über 6.000 durchgeführten Operationsverfahren, darunter 60 Telechirurgie-Einsätze und 310 Herzoperationen.
SS Innovations International (NASDAQ:SSII) أكملت دراسة هامة للتحقق من العوامل البشرية لمنظومة الروبوت الجراحي SSi Mantra في مستشفى جونز هوبكنز في سبتمبر 2025. تخطط الشركة لتقديم إخطار مسبق بـ510(k) إلى FDA في الربع الرابع من 2025، بالتحول من استراتيجيتها السابقة لمسار De Novo.
أبرمت الشركة شراكة مع RQM+، وهو CRO محوري في MedTech، لعملية التقديم وتتوقع الحصول على اعتماد FDA محتمل في النصف الأول من 2026. حاليًا، لدى SSi Mantra قاعدة مركبة من 125 وحدة في 6 دول، مع أكثر من 6,000 إجراء جراحي مكتمل، بما في ذلك 60 إجراءً جراحة عن بُعد و 310 إجراءً قلبياً.
SS Innovations International (NASDAQ:SSII) 已在2025年9月于约翰霍普金斯医院完成了其 SSi Mantra 外科机器人系统的人因因素验证研究。公司计划在2025年第四季度向FDA提交510(k)上市前通知，不再沿用之前的 De Novo 路径策略。
公司已与以MedTech为重点的CRO RQM+建立了提交流程合作关系，预计在2026年上半年获得FDA潜在批准。目前，SSi Mantra 的安装基数为在6个国家/地区的125台，完成了超过6,000例外科手术，其中包括60例远程手术和310例心脏手术。
- Successful completion of human factors validation study at prestigious Johns Hopkins Hospital
- Strong existing market presence with 125 units installed across 6 countries
- Proven track record with over 6,000 successful surgical procedures performed
- Strategic shift to 510(k) pathway offers potential speed and cost advantages over De Novo route
- FDA clearance not guaranteed and timeline could extend beyond H1 2026
- Additional information requests from FDA could delay approval process
Insights
SS Innovations completes key FDA validation study, pivoting to faster 510(k) pathway with potential 2026 US approval.
The successful completion of the human factors validation study at Johns Hopkins Hospital represents a significant regulatory milestone for SS Innovations. This study is crucial evidence demonstrating that the SSi Mantra surgical robotic system meets the FDA's usability and patient safety requirements - a critical component of their upcoming 510(k) submission.
The company's strategic pivot from a De Novo request to the 510(k) regulatory pathway is particularly noteworthy. This change potentially offers two substantial advantages: faster review timelines and lower regulatory costs. The 510(k) pathway is typically used when a device can demonstrate substantial equivalence to a legally marketed predicate device, suggesting SS Innovations has identified comparable approved surgical robotic systems to streamline their approval process.
The anticipated Q4 2025 submission timeline, with potential clearance in H1 2026, aligns with standard FDA review periods for 510(k) submissions (typically 90-180 days). The engagement of RQM+, a specialized MedTech regulatory consultant, further strengthens their submission strategy and increases probability of successful clearance.
The current installed base of 125 systems across six countries with over 6,000 procedures performed provides substantial real-world evidence to support their regulatory filing. The experience with 60 telesurgeries and 310 cardiac procedures demonstrates diverse clinical applications, which will likely strengthen their case for multi-specialty indications in the US market.
Company successfully completed a human factors validation study at Johns Hopkins Hospital
Anticipates submitting a 510(k) premarket notification to the FDA in the fourth quarter of 2025
FORT LAUDERDALE, Fla., Oct. 02, 2025 (GLOBE NEWSWIRE) -- 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 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 and 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.
The completion of the human factors validation study, which is designed to provide essential evidence that the SSi Mantra meets the FDA’s requirements for usability and patient safety, marks a key milestone and will form an important part of the Company’s forthcoming 510(k) submission. The Company has engaged RQM+, a leading MedTech-focused CRO, to assist with the 510(k) submission.
If the FDA determines that the SSi Mantra can be marketed in the United States, the Company believes that such clearance could occur in the first half of 2026 based on standard review timelines, excluding time required by the Company to respond to any additional information requests.
Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “Based on discussions with the FDA and our consultants, we pivoted from filing a De Novo request for our SSi Mantra surgical robotic system to pursuing the 510(k) regulatory pathway, which offers potential speed and cost advantages. We have since made excellent progress as highlighted by the recent completion of a human factors validation study conducted at Johns Hopkins Hospital. This study will be an integral part of our 510(k) premarket notification, which we anticipate submitting to the FDA in the fourth quarter of 2025, bringing us closer to our goal of introducing our advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market.”
As of September 30th, 2025, the SSi Mantra cumulative installed base totaled 125 across six countries where the Company’s surgical robotic system has received regulatory approval. To date, 119 hospitals have installed the SSi Mantra and over 6,000 surgical procedures have been performed, including 60 telesurgeries and 310 cardiac procedures.
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 procedures including robotic cardiac surgery. An American company headquartered in India, SS Innovations plans to expand 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 user-friendly, modular, multi-arm system with many 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. A vision cart provides the table-side team with the same magnified 3D 4K view as the surgeon to provide better safety and efficiency. The SSi Mantra utilizes over 40 different types of robotic endo-surgical instruments to support different specialties, including cardiac surgery. The SSi Mantra has been clinically validated in India in more than 100 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.
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FAQ
When does SS Innovations (SSII) expect FDA clearance for its SSi Mantra surgical robot?
How many SSi Mantra surgical systems has SS Innovations installed globally?
What is the current status of SS Innovations' FDA submission for SSi Mantra?
How many procedures have been performed using the SSi Mantra surgical robot?
Why did SS Innovations change from De Novo to 510(k) FDA submission pathway?
