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MMI receives de novo nod for microsurgery robot

Medical Microinstruments (MMI) secured de novo authorization for its Symani Surgical System, assisting surgeons in reconnecting small blood vessels. The FDA cleared the device for soft tissue manipulation in microsurgery to restore blood flow and redirect fluid during reconstruction or repair.

Microsurgery and supermicrosurgery, involving vessels from 0.3mm to 0.8mm, enable repairing damaged areas with tissue from elsewhere. By reattaching blood vessels, surgeons restore form and function in affected areas.

Robotics offer promise in enhancing these procedures, leading to developments like MMI's Symani and Microsure's Musa. Microsure touted Musa as the world's first surgical robot for open microsurgery, seeking FDA clearance after CE marking in 2019.

MMI's Symani, now the sole U.S. platform for reconstructive microsurgery, aids in various procedures, including post-mastectomy breast cancer reconstruction and extremity reconstruction.

In Europe, Symani aids in free flap surgery, craniofacial and maxillofacial procedures, extremity reconstruction, and lymphatic surgery, though users note longer procedure times, emphasizing the need for additional data.