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Virtual Incision nabs FDA authorization for the MIRA Surgical System as the first miniaturized robotic-assisted surgery device

Press releases may be edited for formatting or style | February 26, 2024 Operating Room

“Colectomy is one of the most complex multi-quadrant abdominal procedures with nearly 50 percent still being performed as open surgery.3 Data from our IDE clinical study demonstrated that MIRA can successfully be used to mobilize the colon in a minimally invasive way,4” said Piet Hinoul M.D., Ph.D., chief medical officer of Virtual Incision. “Starting with a difficult multi-quadrant procedure like a colectomy presents an exciting opportunity for us to address a high unmet need before we expand into other indications. We’re thankful to the investigators and patients who participated in our IDE clinical study that propelled us to marketing authorization.”

Virtual Incision will begin commercialization of MIRA through its First Access Program in centers to be selected across the United States. The company will ramp up MIRA’s production and expand to additional sites over time.

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MIRA’s broader commercialization and expansion of its roadmap for future indications includes gynecology, general surgery, urology and other soft tissue and solid organ surgery. Studies of MIRA in gynecological procedures are planned in 2024. Additionally, a new iteration of the technology tailored to general surgery is in design and expected to be used in a first-in-human study outside the U.S. later this year.

About Virtual Incision
Virtual Incision is on a mission to simplify robotic-assisted surgery (RAS), so more patients and their surgeons can access its benefits every day. Headquartered in Lincoln, Nebraska, and holding over two hundred patents and patent applications, the company developed MIRA, the first-of-its-kind miniature RAS system. Virtual Incision’s goal is to make every operating room RAS-ready. For more information, visit our website or follow us on LinkedIn and X.

About the MIRA Surgical System
MIRA is the world’s first miniaturized robotic-assisted surgery (RAS) system. Its small, sleek form factor is designed to offer the benefits of RAS during colectomy procedures without the logistical inefficiencies of traditional mainframe robotics. The easily accessible device weighs approximately two pounds (less than one kg) and offers internal triangulation with shoulders, arms, and infinite wrist roll inside of the body. It can be used in any operating room – a dedicated mainframe room is unnecessary. With its drape- and dock-free design and portability, MIRA is quick to set up, clean up, and move between cases. Its conveniently accessible design positions it to be used as a standalone system or a complementary tool for facilities that already own a mainframe. With MIRA, every operating room is RAS-ready.

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