SS Innovations (Nasdaq:SSII) announced today that it completed a human factors validation study for its SSi Mantra surgical robot.
The company said it completed the study at Johns Hopkins Hospital last month. It now anticipates submitting an FDA 510(k) premarket notification to the FDA for multiple indications in the fourth quarter of 2025.
Completing the human factors validation study means SS Innovations provided essential evidence that its Mantra system meets the requirements for usability and patient safety. It marks a key milestone as part of the company’s forthcoming FDA submission, according to a news release. The company said it engaged RQM+, a leading medtech-focused CRO, to assist with the submission.
Mantra provides capabilities for multi-specialty usage, including in cardiothoracic, head and neck, gynecology, urology, and general surgery. The platform features a modular, 3D vision, open-console design with superior ergonomics. It engages machine learning models to improve safety and efficiency during procedures.
If the FDA clears Mantra, the company expects it to come in the first half of 2026, based on standard review timelines. This marks a slight delay to initial plans, as the company previously said that it hoped for approvals in the latter half of 2025, initially expecting to submit the system to the FDA in July.
The company completed the first robotic cardiac surgeries in the Americas with the system in June, and then the first robotic telesurgery for weight loss a couple of weeks later. Last month, it announced the world’s first pediatric pyeloplasty telesurgery using Mantra.
“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,” said Chair and CEO Dr. Sudhir Srivastava. “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.”
