|
Take heed to this text  |
MIRA includes a small, self-contained surgical system that may carry out stomach 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 the FDA’s de novo classification course of, with findings primarily based on an investigational system exemption (IDE) research.
Digital Incision’s MIRA system includes a small, self-contained surgical system. 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 can be acquainted to surgeons. Altogether, MIRA weighs about two kilos.
In line with 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 system — a present problem with surgical robots.
“At present marks a turning level in surgical robotics as now we 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 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 know-how and our scientific proof.
“Whether or not as a complement to the prevailing 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 through the Surgical Robotics Week sequence subsequent month.
How the Digital Incision MIRA system bought 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 evaluation in Could 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, Digital Incision accomplished a $46 million Sequence 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 develop to further websites over time. The corporate additionally hopes to pursue further indications, together with gynecology, common surgical procedure, urology and different tender tissue and stable 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 yr.
Editor’s Observe: This text was syndicated from The Robotic Report’s sister website MassDevice.
