Surgical robotic technology developer聽SS Innovations has announced its intention to file a de novo classification request for its SSi Mantra 3 surgical robotic system to the US Food and Drug Administration (FDA) in July.
If the agency approves the submission, the system will be authorised for sale in the US market. The company acknowledges that submitting this request does not ensure approval from the FDA.
The application will request clearance for multi-speciality use, including gynaecology, general surgery, thoracic and urology surgery.
Since the systems became commercially available in August 2022, SS Innovations claims to have installed 80 SSi Mantra systems across 75 hospitals.
Since the release of SSi Mantra 3 in June 2024, the company has installed 37 systems that have reportedly been used in more than 750 multi-speciality surgeries. These include 70 cardiac cases, without any reports of device-related injury, complications, or deaths.
According to SS Innovations, the real-world clinical data has been validated by a contract research organisation and provides support for SSi Mantra 3’s capability to safely conduct a broad range of surgeries.
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By GlobalDataSS Innovations board chairman and CEO Dr Sudhir Srivastava said: 鈥淲e currently have approval to market our SSi Mantra surgical robotic system in six countries and continue to advance our global expansion. We are taking important steps, including the planned de novo application to the FDA, to introduce our empowering, cost-effective surgical robotic technology to the US market.
鈥淚n parallel, we are pursuing European Union CE Mark approval for our SSi Mantra surgical robotic system and look forward to our future with great confidence.鈥�
SS Innovations noted that its SSi Mantra Surgical Robotic System features three to five modular robotic arms, an open-faced ergonomic surgeon command centre, and a 3D ultra-high definition [4K] monitor setup.
It also features a virtual real-time image of robotic patient side arm carts, a touch panel for patient information, and the superimposition ability of 3D diagnostic imaging models.
The company noted that more than 40 different robotic endo-surgical instrument types are leveraged by the system, catering to various specialities, inclusive of cardiac surgery. The system has been validated clinically in India for over 100 surgical procedures.
Last November, the company reported carrying out Indonesia’s first robotic cardiac surgery using the SSi Mantra system.
