MMI Gains FDA Clearance and Completes First U.S. Robotic Microsurgery with Symani

Medical Microinstruments, Inc. (MMI), has received FDA 510(k) clearance for its NanoWrist® Scissors and Forceps for soft tissue dissection. 

This clearance allows delicate tissue manipulation in robotic microsurgery, expanding the Symani® Surgical System’s use beyond anastomosis to include additional critical steps in complex procedures.

The first U.S. clinical use of the cleared instruments was completed at Tampa General Hospital (TGH) during a lymphovenous bypass (LVB) procedure. 

This represents the world’s first fully robotic-assisted microsurgical operation from initial incision to skin closure. Using the NanoWrist Scissors and Forceps, surgeons were able to access the surgical site, perform precise tissue dissection, and prepare lymphatic vessels and veins for bypass. 

The procedure was completed with other NanoWrist instruments, all offering seven degrees of freedom, motion scaling, and tremor reduction for enhanced precision.

MMI’s dissection instruments are the world’s first fully wristed robotic tools designed for open microsurgery, aimed at preserving tissue integrity and reducing vessel trauma. 

They are particularly valuable in complex procedures such as surgical lymphatic repair, perforator-to-perforator reconstruction, and cancer-related head and neck reconstruction.

This development builds on MMI’s recent milestones, including expansion into neurosurgery, launching the largest U.S. robotic microsurgery clinical trial, and advancing digital surgery and reimbursement support for select procedures.