Earlier this year, the company completed its first interactive pre-submission meeting with the FDA for SSi Mantra. It said in a news release that it received feedback to help it proceed with a de novo pathway pre-market submission. The company plans to submit Mantra for a number of indications in parallel.
SS Innovations plans to conduct follow-on pre-submission meetings with the FDA in the coming months. It expects to submit the SSi Mantra for investigational device exemption (IDE) in the first quarter of 2025 to initiate clinical trials. The company plans to simultaneously conduct clinical trials for various indications, including abdominal, pelvis, thoracic and cardiac.
According to a news release, the company believes it can meet clinical trial requirements “relatively quickly.” It attributed this to the robot’s safety, efficacy and performance in already ongoing clinical use in India. The company says that, under applicable FDA protocols, procedures performed in India can be included in the clinical trials. SS Innovations also plans to conduct some of its trials in the U.S., particularly evaluating cardiac applications.
“The company estimates that, barring any unanticipated developments, it should be able to secure its pre-market approvals by the end of 2025,” SS Innovations concluded.
News of the updated timeline follows yesterday’s announcement that SS Innovations added Dr. Fred Moll to its board. Moll, the co-founder of surgical robotics leader Intuitive Surgical, brings decades of experience to the company.
