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FDA Grants Approval for MMI to Introduce Symani® Surgical System in the U.S.

Monday, April 08, 2024

MMI, a robotics company committed to advancing treatment options and enhancing patient outcomes for those with complex medical conditions, has announced the launch of its Symani® Surgical System in the United States. This comes after the U.S. Food and Drug Administration (FDA) granted De Novo Classification to the robotic system, specifically designed for microsurgery procedures involving soft tissue manipulation. These procedures are crucial for reconnecting tiny vessels during reconstruction or repair surgeries.

With FDA approval, the Symani Surgical System becomes the sole commercially available platform in the U.S. for reconstructive microsurgery. It aims to democratize microsurgery by providing a pathway for both new and experienced surgeons to perform intricate procedures with greater precision and control. These procedures include reconnecting small anatomical structures like blood and lymphatic vessels during open surgeries, as well as supermicrosurgery, which involves even smaller vessel reconstruction.

The Symani Surgical System introduces new capabilities for various open surgeries, such as post-mastectomy breast cancer reconstruction, extremity reconstruction using free tissue transfer, and lymphatic system repair. Its NanoWrist® technology, featuring the world's smallest surgical robotic wrist, enables surgeons to replicate natural hand movements at a micro scale. With features like tremor filtration and motion scaling, the system enhances precision and control, facilitating an easier learning curve for surgeons in training.

Having been utilized in numerous clinical and preclinical cases globally, the Symani Surgical System has demonstrated its effectiveness in advancing surgical capabilities. While currently available in Europe and parts of Asia Pacific, MMI plans to introduce the technology immediately in the U.S., paving the way for advancements in microsurgery and beyond.

Source: businesswire.com