Virtual Incision Gains FDA Marketing Authorization

Virtual Incision Gains FDA Marketing Authorization

By, Admin 29 February 2024

Virtual Incision receives US FDA marketing authorization for miniaturized robotic-assisted surgery device

Overview

Virtual Incision, a cultivate (MD) portfolio company, has been received marketing authorization of the MIRA Surgical System (MIRA) from the US FDA. This marks a significant milestone as MIRA becomes the first miniaturized robotic-assisted surgery device in the world approved for adult colectomy procedures.

Words from Virtual Incision

R. Sean Churchill, MD, MBA, managing director of cultivate (MD), expressed enthusiasm for the US FDA approval. ""Cultivate (MD) Capital Funds is proud to have partnered with Virtual Incision Corporation along their developmental journey. We have long recognized the need for mainstream robotics in medicine that can simultaneously provide minimally invasive surgery with system portability allowing use in large university based hospital systems as well as smaller community hospitals, all in a cost effective, efficient manner. Virtual Incision Corporation accomplished these goals and has redefined the future of robotic surgery.""

Aim for Robotic Surgery Integration

  • Virtual Incision views MIRA's innovative design as a potential game-changer in the realm of surgical technology. 
  • With its compact size (weighing less than two pounds) and a user-friendly tray-to-table setup, MIRA is designed to with the hopes of enhancing operating room efficiency. 
  • This innovative approach aims to facilitate the integration of robotic surgery in a wider range of healthcare settings, potentially overcoming the logistical challenges associated with the large surgical robots that are currently available.

Director’s Words from Virtual Incision

"We have been in awe of watching this incredible innovative technology and team for years, creating and thinking outside of the box,"" said David Blue, Director of cultivate (MD) Capital Funds. ""These miniature robots will be the future, and they will continue to amaze the rest of the surgical robotics world, and it will be fun seeing them lead us into this new world! We are so excited and honored to be on this journey with Virtual Incision!""

Mira’s Commercial Entry

With US FDA authorization in hand, Virtual Incision is set to initiate MIRA's commercial rollout in select centers in the United States.

Mira’s Future Indications

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.

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 US later this year.

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