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The FDA has granted de novo Classification to MMI's (Medical Microinstruments Inc.) Symani Surgical System, making it the only robotic platform in the U.S. specifically designed for soft tissue manipulation in microsurgery procedures.
Microsurgery, a discipline characterized by the reconnection of tiny blood vessels and lymphatic vessels to facilitate reconstruction or repair, demands high precision and skill, particularly in surgeries less than 1 mm in diameter known as supermicrosurgery. The FDA's nod toward Symani aims to bridge the current gap in the healthcare system by expanding the capabilities of both emerging and experienced microsurgeons through robotic assistance. This technological leap not only intends to enhance the surgical precision but also to make such intricate procedures more accessible, potentially increasing patient access to advanced surgical techniques.
MMI's CEO, Mark Toland, underscored the pressing need for such innovations against the backdrop of a looming physician shortage in the U.S., particularly in specialized fields like microsurgery. The Symani Surgical System is seen as a pivotal solution to this challenge, enabling a broader spectrum of physicians to perform complex surgeries and thereby expanding the treatment options available to patients with conditions such as lymphedema.
The system boasts the NanoWrist, the world's smallest surgical robotic wrist, designed to mimic the natural dexterity of the human hand but at a micro level. This feature is expected to streamline the learning curve for surgeons, enhancing their ability to perform precise and controlled movements during surgery. The Symani Surgical System has already been utilized in nearly 1,000 clinical cases across the EU and in numerous preclinical studies globally.
With its launch in the U.S., the Symani Surgical System expands the scope of reconstructive surgeries, including post-mastectomy breast reconstruction, extremity reconstruction using free tissue transfer, and lymphatic system repair.
