Virtual Incision announced that the FDA granted marketing authorization to its MIRA miniaturized surgical robotic system.
The FDA gave the nod for the use of the miniRAS (robotic-assisted surgery) device in adults undergoing colectomy procedures. MIRA went through the FDA’s de novo classification process, with findings based on an investigational device exemption (IDE) study.
Virtual Incision’s MIRA system features a small, self-contained surgical device. Inserted through a single midline umbilical incision in the patient’s abdomen, it allows for complex, multi-quadrant abdominal surgeries. The system also uses existing minimally invasive tools and techniques that are familiar to surgeons. Altogether, MIRA weighs about two pounds.
According to the company, the system’s tray-to-table design could provide the advantages of robotic surgery without requiring them to organize the operating room around the device — a current challenge with surgical robots.
“Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturized robotic surgery a reality,” said Virtual Incision President and CEO John Murphy. “For more than a decade, our team has been dedicated to our core mission of making every operating room robot-ready. I’m incredibly proud to see our efforts come to fruition. We extend our gratitude to the FDA for its thoughtful review of MIRA’s technology and our clinical evidence.
“Whether as a complement to the existing mainframes or as a stand-alone platform, miniaturization has the potential to accelerate the adoption of robotic-assisted surgery.”
Hear from Virtual Incision during the DeviceTalks Tuesdays Surgical Robotics Week series next month.
How the Virtual Incision MIRA system got here
The MIRA platform received IDE approval in October 2020, followed by approval for an IDE supplement in April. Virtual Incision submitted MIRA to the FDA for de novo review in May 2023. Notably, MIRA went to space last month, with NASA awarding a grant to use the system on a 2024 technology demonstration mission.
In November 2021, Virtual Incision completed a $46 million Series C financing round to support the robotic surgery platform. Virtual Incision then raised $30 million more in September 2023.
Virtual Incision plans to begin commercialization of MIRA through a first access program across select U.S. centers. It plans to ramp up production and expand to additional sites over time. The company also hopes to pursue additional indications, including gynecology, general surgery, urology and other soft tissue and solid organ surgery.
It plans for gynecological procedures in 2024. Additionally, Virtual Incision has a new iteration of the technology tailored for general surgery in its design stage. It expects first-in-human uses outside the U.S. later this year.