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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 and marketing 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 system exemption (IDE) examine.

Digital Incision’s MIRA system includes a small, self-contained surgical system. Inserted by way of 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 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 the moment marks a turning level in surgical robotics as now we have hit a big milestone in making miniaturized robotic surgical procedure a actuality,” stated Digital Incision President and CEO John Murphy. “For greater than a decade, our workforce 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 evaluate of MIRA’s expertise 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 throughout 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 evaluate in Might 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 Sequence 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 way of 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 delicate 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 exterior the U.S. later this yr.

Editor’s Word: This text was syndicated from The Robotic Report’s sister web site MassDevice.