Take heed to this text
![](https://www.therobotreport.com/wp-content/uploads/2024/03/Virtual-Incision-MIRA-Platform-768x499-1.webp)
MIRA includes a small, self-contained surgical gadget that may carry out belly surgical procedures. | Supply: Digital Incision
Digital Incision introduced that the FDA granted advertising 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 gadget exemption (IDE) examine.
Digital Incision’s MIRA system includes a small, self-contained surgical gadget. Inserted by a single midline umbilical incision within the affected person’s stomach, it permits for complicated, multi-quadrant belly surgical procedures. The system additionally makes use of current minimally invasive instruments and methods which might be acquainted to surgeons. Altogether, MIRA weighs about two kilos.
Based on the corporate, the system’s tray-to-table design may present the benefits of robotic surgical procedure with out requiring them to prepare the working room across the gadget — a present problem with surgical robots.
“At the moment marks a turning level in surgical robotics as we’ve hit a major milestone in making miniaturized robotic surgical procedure a actuality,” stated Digital Incision President and CEO John Murphy. “For greater than a decade, our staff 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 lengthen our gratitude to the FDA for its considerate evaluation 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 sequence subsequent month.
How the Digital Incision MIRA system received right here
![](https://www.therobotreport.com/wp-content/uploads/2024/03/VIC-PS-6495-1-768x499-1.jpeg)
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 evaluation in Could 2023. Notably, MIRA went to house 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 help 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 increase to extra websites over time. The corporate additionally hopes to pursue extra indications, together with gynecology, common surgical procedure, urology and different mushy 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 common surgical procedure in its design stage. It expects first-in-human makes use of outdoors the U.S. later this 12 months.
Editor’s Be aware: This text was syndicated from The Robotic Report’s sister web site MassDevice.