February 24, 2024 – Virtual Incision Corporation, a pioneer in robotic surgery, has announced the FDA approval of its MIRA™ surgical robot, the world's first miniaturized system designed to assist with colon resections. Having previously submitted a De Novo request, this groundbreaking device has achieved marketing authorization based on compelling results from clinical studies under the FDA's Investigational Device Exemption (IDE) framework.
Introducing MIRA™: The Trailblazer in Miniaturized Robotic-Assisted Surgery
MIRA™'s FDA clearance heralds a new era in minimally invasive surgery (MIS). Its miniaturized form factor expands the possibilities of MIS for complex surgeries by offering surgeons unprecedented precision and control, traditionally only possible with larger systems. Despite the clear benefits of robotic-assisted surgery, the adoption has been slow; nearly 90% of US operating rooms lack such technology due to logistical complexities, specialized training requirements, and significant costs.
Virtual Incision's MIRA™ addresses these barriers with its innovative "tray-to-operating table" design, eliminating the need for specialized robotic surgery suites. The compact, portable system weighs less than one kilogram and is designed to drastically reduce setup time, allowing for quick and easy integration into any operating room setting.
Virtual Incision, with over 200 patents, is at the forefront of simplifying robotic-assisted surgeries, democratizing access to this technology. MIRA™ is a first-of-its-kind, portable, and versatile RAS platform, poised to redefine the use of surgical robots in a range of procedures.
The MIRA™ system includes a micro-arm, support cart, and surgeon's console. The micro-arm, weighing just 2 pounds, is particularly well-suited for tight spaces, including potential use in space missions. It features a disposable end effector, bipolar grasper, monopolar scissors, and a flexible-tip robotic camera system – a first in the world – for superior visualization.
With this FDA approval, Virtual Incision's MIRA™ is set to transform the landscape of surgical care, making advanced robotic assistance a reality for healthcare facilities nationwide.
Leadership Insights and Vision for the Future
John Murphy, Virtual Incision's CEO, expressed his pride in this regulatory milestone: "This FDA clearance is a transformative moment for the surgical robotics field, signifying a major milestone for our company in the realm of miniaturized robotic surgery. Our team's decade-long commitment to making surgical robots accessible in every OR is now coming to fruition. We're thankful for the FDA's recognition of MIRA™ as a potential game-changer in expanding the adoption of robotic-assisted surgery."
Dr. Piet Hinoul, Virtual Incision's CMO, highlighted MIRA™'s clinical impact: "Colon resection, a highly complex surgery, is still predominantly performed using traditional open methods. Our IDE clinical study data shows MIRA™'s capability to perform these procedures minimally invasively. This robot meets a crucial need in colon resection and paves the way for future applications."
Virtual Incision will commence the commercial rollout of MIRA™ through its "First Access Program" in select US centers, with plans to ramp up production and expand to more locations over time.
About Virtual Incision Corporation
Virtual Incision, established in 2006, is a spinoff from the University of Nebraska-Lincoln, headquartered in Pleasanton, California. It is a medical device company that has developed the world's first miniaturized robotic-assisted surgery (RAS) platform. The company was co-founded by Shane Farritor, a professor of engineering at the University of Nebraska, who has studied at Kennedy Space Center, Goddard Space Flight Center, and Jet Propulsion Laboratory, and Dmitry Oleynikov, a surgeon at the university's medical center.