FDA Authorizes Virtual Incision’s First Miniaturized Robotic-Assisted Surgery Device

Virtual Incision was granted marketing authorization by the FDA for the MIRA Surgical System (MIRA). MIRA becomes the first miniaturized robotic-assisted surgery device in the world approved for adult colectomy procedures. FDA authorization was based partly on the company’s U.S. Investigational Device Exemption (IDE) clinical study findings.

cultivate(MD) Capital Funds partnered with Virtual Incision Corporation for the development of the device and sees the design as a potential game-changer in the realm of surgical technology. Featuring a compact size (less than two pounds) and a user-friendly tray-to-table setup, the goal is to enhance operating room efficiency and facilitate the integration of robotic surgery in a wider range of healthcare settings.

The miniature robots are expected to take hold in the future. With its FDA authorization, Virtual Incision is set to initiate MIRA’s commercial rollout in select centers in the United States. MIRA’s roadmap for the future includes gynecology, general surgery, urology, and other soft tissue and solid organ surgery. 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.

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