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MIRA includes a small, self-contained surgical machine that may carry out stomach surgical procedures. | Source: Virtual Incision
Virtual Incision introduced that the FDA granted advertising and marketing authorization to its MIRA miniaturized surgical robotic system.
The FDA gave the nod for using the miniRAS (robotic-assisted surgical procedure) system in adults present process colectomy procedures. MIRA went by the FDA’s de novo classification course of, with findings primarily based on an investigational machine exemption (IDE) research.
Virtual Incision’s MIRA system includes a small, self-contained surgical machine. Inserted by a single midline umbilical incision within the affected person’s stomach, it permits for complicated, multi-quadrant stomach surgical procedures. The system additionally makes use of current minimally invasive instruments and methods which can be acquainted to surgeons. Altogether, MIRA weighs about two kilos.
According to the corporate, the system’s tray-to-table design may present some great benefits of robotic surgical procedure with out requiring them to prepare the working room across the machine — a present problem with surgical robots.
“Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” stated Virtual Incision President and CEO John Murphy. “For greater than a decade, our crew has been devoted to our core mission of constructing each working room robot-ready. I’m extremely proud to see our efforts come to fruition. We prolong our gratitude to the FDA for its considerate evaluation of MIRA’s know-how and our scientific proof.
“Whether as a complement to the existing mainframes or as a stand-alone platform, miniaturization has the potential to accelerate the adoption of robotic-assisted surgery.”
Hear from Virtual Incision throughout the Surgical Robotics Week collection subsequent month.
How the Virtual Incision MIRA system obtained right here
A surgeon holds the miniature MIRA surgical robotic. | Source: Virtual Incision
The MIRA platform acquired IDE approval in October 2020, adopted by approval for an IDE complement in April. Virtual Incision submitted MIRA to the FDA for de novo evaluation in May 2023. Notably, MIRA went to area final month, with NASA awarding a grant to make use of the system on a 2024 know-how demonstration mission.
In November 2021, Virtual Incision accomplished a $46 million Series C financing spherical to help the robotic surgical procedure platform. Virtual Incision then raised $30 million extra in September 2023.
Virtual Incision plans to start commercialization of MIRA by a primary entry program throughout choose U.S. facilities. It plans to ramp up manufacturing and increase to further websites over time. The firm additionally hopes to pursue further indications, together with gynecology, basic surgical procedure, urology and different tender tissue and strong organ surgical procedure.
It plans for gynecological procedures in 2024. Additionally, the corporate has a brand new iteration of the know-how tailor-made for basic surgical procedure in its design stage. It expects first-in-human makes use of outdoors the U.S. later this yr.
Editor’s Note: This article was syndicated from The Robot Report’s sister website MassDevice.