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FDA Authorization for MIRA Surgical System

by Marco van der Hoeven

Virtual Incision Corporation, a Nebraska-based medical device company, announced that its MIRA Surgical System (MIRA) has been authorized for marketing by the U.S. Food and Drug Administration (FDA). This authorization marks the introduction of the first miniaturized robotic-assisted surgery (miniRAS) device into the medical field. The MIRA system is specifically approved for adult colectomy procedures, a type of surgery that involves the removal of part or all of the colon.

This FDA authorization comes through the De Novo Classification process, a regulatory pathway for novel medical devices that lack a comparable device on the market. The decision was partly based on the results from a U.S. Investigational Device Exemption (IDE) clinical study conducted by Virtual Incision.

John Murphy, the President and CEO of Virtual Incision, emphasized the significance of this development in the field of surgical robotics. He highlighted the company’s long-term commitment to making robotic surgery more accessible and versatile, and expressed gratitude to the FDA for their thorough review of MIRA’s technology and clinical evidence.

The MIRA system represents a significant advancement in the field of minimally invasive surgery (MIS). Traditional MIS techniques, known for smaller incisions and potentially reduced recovery times, have been further enhanced by robotic-assisted surgery, offering greater precision and control. However, the widespread adoption of robotic-assisted surgery has been limited by factors such as the need for dedicated operating room space, specialized staff training, lengthy setup times, and high costs. MIRA aims to address these barriers with its compact, portable design that can be easily integrated into existing operating room setups.

The device, weighing less than one kilogram, is designed for quick setup, potentially allowing any operating room to be equipped for robotic surgery within minutes. This “in-a-tray” form factor of the MIRA system could make robotic-assisted surgery more accessible to a larger number of healthcare facilities.

Dr. Piet Hinoul, Chief Medical Officer of Virtual Incision, noted the importance of introducing the MIRA system with colectomy procedures, given their complexity and the current prevalence of open surgery in these cases. He also mentioned the successful use of MIRA in colon mobilization during the IDE clinical study, indicating the potential for the device in other surgical applications.

Virtual Incision plans to commence the commercialization of MIRA through its First Access Program, initially introducing the device in select U.S. centers, with plans for gradual expansion and production ramp-up. The company also outlined its roadmap for future applications of the MIRA system, including in gynecology, general surgery, and urology, among other specialties. Further studies and iterations of the MIRA technology are planned for 2024, including its use in gynecological procedures and a new design tailored for general surgery, expected to be tested in a first-in-human study outside the U.S. later in the year.


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