SS Innovations to submit SSi Mantra 3 to FDA in July

The SSi Concept 3 consists of 40+ robot medical tools that can be utilized for various specializeds consisting of heart surgical procedure.|Resource: SS Developments

SS Developments intends to send an afresh category demand to the united state FDA for its SSi Concept 3 medical robot system. Ft Lauderdale, Florida-based SS Developments intends to send in July. The entry will certainly consist of an application for multi-specialty signs, consisting of urology, gynecology, basic surgical procedure, and thoracic and heart surgical procedure.

The SSI Concept 3 system includes a modular, open-console style with 3D visualization and boosted comfort designs. Integrated equipment discovering versions better boost step-by-step security and performance. Surgical robotics professionals have actually defined SS Developments as a firm to view

Because the business started marketing its system in August 2022, it has actually set up 80 SSi Concept robot medical systems in 75 healthcare facilities. Over 3,800 surgical treatments have actually been carried out, consisting of over 200 robot heart surgical treatments.

The SSi Concept 3 variation was introduced in June 2024, and SS Developments has actually currently set up 37 systems. These have actually been used to execute greater than 750 multi-specialty robot procedures, consisting of 70 heart instances. The business reports no device-related death, injury, or issues.

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According to SS Developments, real-world medical information confirmed by a leading agreement research study company sustains the SSi Concept 3’s capacity to securely execute a variety of procedures.

” We presently have authorization to market our SSi Concept medical robot system in 6 nations and remain to progress our international growth,” Sudhir Srivastava, board chair and chief executive officer of SS Developments, stated in a press release.

” We are taking vital actions, consisting of the organized afresh application to the FDA, to present our empowering, affordable medical robot innovation to the united state market. In parallel, we are going after European Union CE Mark authorization for our SSi Concept medical robot system and anticipate our future with wonderful self-confidence.”

SS Developments bank on robot telesurgery

Previously this year, SS Developments finished 5 robot heart telesurgeries, of enhancing intricacy, throughout greater than 250 kilometres (155 mi.). These treatments are simply a very early action in its objective to equalize accessibility to innovative medical care, Dr. Vishwa Srivastava, primary running police officer of SS Developments, informed The Robotic Record in February.

The business’s newest system, the SSI Concept 3, is less costly User-friendly Surgical’s da Vinci system. Launched in July 2024, SSI Concept 3 got regulative authorization for remote surgical procedure and teleproctoring from the Central Drugs Requirement Control Company (CDSCO), unlocking for remote surgical treatments and clinical education and learning.

The system has an open-faced ergonomic Doctor Command Centre, a 32-in. 3D 4K display, and a 23-in. 2D touch-panel display to show all patient-related details. It additionally gives a digital real-time photo of the robot Person Side Arm Carts and can lay over 3D versions of analysis imaging.

Editor’s Note: This short article was syndicated from The Robotic Record’s brother or sister website MassDevice.

The article SS Developments to send SSi Concept 3 to FDA in July showed up initially on The Robotic Record.