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MIRA encompasses a small, self-contained surgical machine that may carry out stomach surgical procedures. | Supply: Digital Incision
Digital 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 based mostly on an investigational machine exemption (IDE) examine.
Digital Incision’s MIRA system encompasses 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 present minimally invasive instruments and methods which are acquainted to surgeons. Altogether, MIRA weighs about two kilos.
In response to the corporate, the system’s tray-to-table design may present the benefits of robotic surgical procedure with out requiring them to arrange the working room across the machine — a present problem with surgical robots.
“Immediately marks a turning level in surgical robotics as we now have hit a big milestone in making miniaturized robotic surgical procedure a actuality,” mentioned Digital Incision President and CEO John Murphy. “For greater than a decade, our crew has been devoted to our core mission of creating 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 overview of MIRA’s expertise and our medical proof.
“Whether or not as a complement to the present mainframes or as a stand-alone platform, miniaturization has the potential to speed up the adoption of robotic-assisted surgical procedure.”
Hear from Digital Incision in the course of the Surgical Robotics Week collection subsequent month.
How the Digital Incision MIRA system received right here
A surgeon holds the miniature MIRA surgical robotic. | Supply: Digital Incision
The MIRA platform obtained IDE approval in October 2020, adopted by approval for an IDE complement in April. Digital Incision submitted MIRA to the FDA for de novo overview in Might 2023. Notably, MIRA went to area final month, with NASA awarding a grant to make use of the system on a 2024 expertise demonstration mission.
In November 2021, Digital Incision accomplished a $46 million Collection C financing spherical to assist the robotic surgical procedure platform. Digital Incision then raised $30 million extra in September 2023.
Digital Incision plans to start commercialization of MIRA by a primary entry program throughout choose U.S. facilities. It plans to ramp up manufacturing and develop to extra websites over time. The corporate additionally hopes to pursue extra indications, together with gynecology, normal surgical procedure, urology and different smooth tissue and strong organ surgical procedure.
It plans for gynecological procedures in 2024. Moreover, the corporate has a brand new iteration of the expertise tailor-made for normal surgical procedure in its design stage. It expects first-in-human makes use of exterior the U.S. later this yr.
Editor’s Observe: This text was syndicated from The Robotic Report’s sister website MassDevice.