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MIRA encompasses a small, self-contained surgical machine 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 the usage of the miniRAS (robotic-assisted surgical procedure) system in adults present process colectomy procedures. MIRA went by way of the FDA’s de novo classification course of, with findings based mostly on an investigational machine exemption (IDE) research.
Digital Incision’s MIRA system encompasses a small, self-contained surgical machine. Inserted by way of 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 present minimally invasive instruments and strategies which can be acquainted to surgeons. Altogether, MIRA weighs about two kilos.
Based on the corporate, the system’s tray-to-table design might present some great benefits of robotic surgical procedure with out requiring them to arrange the working room across the machine — a present problem with surgical robots.
“In the present day marks a turning level in surgical robotics as we now have 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 group 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 assessment of MIRA’s know-how and our scientific 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 acquired right here
A surgeon holds the miniature MIRA surgical robotic. | Supply: Digital Incision
The MIRA platform acquired IDE approval in October 2020, adopted by approval for an IDE complement in April. Digital Incision submitted MIRA to the FDA for de novo assessment in Might 2023. Notably, MIRA went to house final month, with NASA awarding a grant to make use of the system on a 2024 know-how 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 way of a primary entry program throughout choose U.S. facilities. It plans to ramp up manufacturing and develop to further websites over time. The corporate additionally hopes to pursue further indications, together with gynecology, common surgical procedure, urology and different gentle tissue and strong organ surgical procedure.
It plans for gynecological procedures in 2024. Moreover, the corporate has a brand new iteration of the know-how 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.