SS Innovations, an Indian company making the SSI Mantra Robot a new option for robotic surgery and telesurgery in India, has filed an application for a 510(k) premarket certification from the US Food and Drug Administration.
The Mantra has achieved succes in several areas, including cardiac, urologic, gynecologic, colorectal and general surgical procedures. In addition to their surgical success' the Mantra is also recognized for being more cost-efficient, when compared to the da Vinci Surgical System. They have units deployed in several countries. SSI has also applied for the European CE mark.
From the SSI December 8th press release:
"Dr. Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations, commented, “Our submission of a 510(k) premarket notification to the FDA marks an important milestone in our strategic plan to introduce the Company’s advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market. Given its affordability, differentiated technology, and proven performance across our existing global installations, we believe the SSi Mantra represents a highly compelling option for hospitals and surgeons in the United States, especially those serving underserved patient communities.”
Based on a pre-submission meeting and subsequent discussions with the FDA, the Company decided to pursue a 510(k) submission, rather than a De Novo request for the SSi Mantra surgical robotic system, aiming to benefit from the pathway’s potential speed and cost efficiencies.
The FDA has stated that its goal is to complete reviews of 510(k) submissions within 90 days of receipt. However, time to approval could be longer due to factors such as the 15-day acceptance review, the submission of additional information, and a submitter's response time."
