SS Innovations Submits SSi Mantra Surgical Robot for FDA Clearance, Targeting U.S. Market Entry in 2027

SS InnovationsAnnouncing that it has submitted to the FDA its soft tissue surgical robot---SSi MantraRegistration Application. This SubmissionSSi MantraThe intended use of the registration application is very broad.Pan, includingGeneral Surgery, Urology, Colorectal Surgery, Gynecology, and Cardiac Surgery.(The intended use is much broader than that of Medtronic's recently approved Hugo surgical robot)

Executive Evaluation

"In view of its cost-effectiveness, differentiated technology, and proven performance in our existing global installed base, we believe SSi Mantra is a highly attractive option for hospitals and surgeons in the U.S., particularly for institutions serving underserved patient populations."

---Sudhir Srivastava  CEO and Founder of SS Innovations

According toSS InnovationsIt is predicted that the FDA willCompletion of registration review within 90 days means next yearSSi MantraExpected to be launched in the United States. In addition, SS Innovations is alsoInSeeking CE Approval, and is expected to be obtained in the first half of 2026.

CurrentlySSi MantraAlready launched in eight countries, with 138 units installed and over 7,300 surgeries completed (Including 88 cases of remote surgery and 390 cases of cardiac surgery). FromSS InnovationsData ReleaseSSi MantraThe performance in non-mainstream markets is still decent. However, for rapid development, recognition in mainstream markets, especially in the U.S., is essential.The United States is currently the world's largest surgical robot market, and this market is currentlyRuled by Intuitive.

SS InnovationsHoping to rely onLow-cost, multi-specialty soft tissue surgical robot &Intuitive Competes (SSi MantraCost is less thanIntuitive Da Vinci Series RobotsOne-third），And can fromA part of the market that Intuitive has captured. Also becauseSSi MantraLow cost, also attractiveFounder of IntuitiveFrederic MOll joins and takes officeVice Chairman of the Board.

Although Indians are known for their boasting, their performance in the TAVI and surgical robotics fields is highly commendable and worth learning from for companies in China. Particularly in the TAVI field,Meril demonstrates through head-to-head trials that its TAVI product is not inferior to those of Medtronic and Edwards, and even surpasses them in some metrics.Medtronic and Edwards TAVI products.

Compared to the boldness of Indian companies, Chinese enterprises tend to be more reserved, lacking the courage to compete head-on in mainstream markets and with mainstream medical devices in Europe and America.

SSi Mantra

SSi MantraSomewhat similarFor Hugo, it belongs to the split-type soft tissue surgical robot. It consists of a console,Composed of a bedside robotic arm and an imaging system.

• Console

Open Design

Large 3D, 4K Monitor Vision

2D Touch Display

• Bedside Robotic Arm

Modular Design

Mobile Design

Depending on the surgical requirements, 3, 4, or 5 mechanical valves can be configured.

Absolutely Stable Stop Button

• Imaging System

Provide Large 3D, 4K Clear Vision for Operating Room Staff