Joe Mullings & Vishwa Pascual Srivastava l SS Innovations & The Mantra Platform

SS Innovations has had great activity going on as it recently completed its 2000th case as well as sharing that is has advanced conversations in regard to the Mantra platform with the FDA and its projected path to use in the US.

In my recent conversation with Vishwa Pascual Srivastava, MD we discussed SS Innovations pathway forward as a digital surgery company with the Mantra platform being an example of how it approaches the surgical and interventional robotic market for best in class care.

The company issued an update on the FDA approval timeline for its Mantra surgical robotic system following meetings with the FDA and to proceed with a de novo pathway pre-market submission.

SS Innovations plans to conduct follow-on pre-submission meetings with the FDA in the coming months and expects to submit the SSI Mantra for investigational device exemption (IDE) in the first quarter of 2025 to initiate clinical trials.

It attributed this to the robot’s safety, efficacy and performance in already ongoing clinical use with over 2000 cases successfully completed with no adverse events.

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.

Congratulations to Sudhir Srivastava, MD and the SSI team as it pushes the market forward. Santiago Horgan also was at headquarters this past week on Mantra.