FDA authorizes Virtual Incision’s MIRA: A leap forward in robotic-assisted surgery

Virtual Incision Corporation has achieved a groundbreaking milestone with the U.S. Food and Drug Administration (FDA) granting marketing authorization for the MIRA Surgical System (MIRA), marking the world’s first miniaturized robotic-assisted surgery (miniRAS) device approved for use in adult colectomy procedures. This landmark decision, facilitated through the FDA’s De Novo Classification process, underscores a significant advancement in surgical technologies and a leap toward making robotic surgery more accessible and efficient in operating rooms across the United States.

John Murphy, President and CEO of Virtual Incision, shared the announcement during the SAGES 5th Annual Next Big Thing Innovation Weekend in Houston, highlighting the pivotal role MIRA is set to play in the evolution of surgical robotics. “This represents a major milestone in miniaturized robotic surgery, propelling us closer to our goal of equipping every operating room with robotic capabilities,” Murphy stated. His comments reflect a decade-long commitment to innovation aimed at enhancing surgical outcomes and operational efficiencies.

The MIRA Surgical System’s approval is based on compelling evidence from the company’s U.S. Investigational Device Exemption (IDE) clinical study, demonstrating its potential to revolutionize minimally invasive surgery (MIS). MIS techniques, known for smaller incisions, less pain, and quicker recovery times, have been further optimized with robotic-assisted surgery offering unprecedented precision and control. However, the widespread adoption of robotic surgery has been hindered by logistical and financial challenges. MIRA’s compact design aims to address these barriers, offering a “in-a-tray” solution that can easily integrate into existing operating room workflows without the need for specialized infrastructure or training.

MIRA’s potential extends beyond logistical improvements. According to Piet Hinoul, M.D., Ph.D., Chief Medical Officer of Virtual Incision, the device has shown promising results in colectomy procedures, traditionally one of the most complex surgeries. The successful use of MIRA in these procedures signals a significant step forward in surgical care, potentially expanding the scope of robotic-assisted surgeries to include a wider range of medical interventions.

Virtual Incision plans to commence the commercialization of MIRA through its First Access Program, selecting centers across the United States for initial deployment. The company is poised for a phased expansion, aiming to increase MIRA’s availability and exploring broader applications in gynecology, general surgery, urology, and other fields. With further studies planned and new iterations of the technology in development, Virtual Incision is at the forefront of a surgical revolution, promising to enhance patient care through innovation and accessibility.

MIRA’s FDA authorization not only marks a significant achievement for Virtual Incision but also represents a promising development in the future of surgical technology. As healthcare facilities look to adopt more advanced and efficient surgical solutions, MIRA stands out as a pioneering tool that could significantly impact millions of patients annually.