Virtual Incision wins FDA nod for miniature MIRA surgical robot for use in colectomies

[Image from Virtual Incision]Virtual Incision announced that the FDA granted marketing authorization to its MIRA miniaturized surgical robotic system.

The FDA gave the nod for the use of the miniRAS (robotic-assisted surgery) device in adults undergoing colectomy procedures. MIRA went through the FDA’s de novo classification process, with findings based on an investigational device exemption (IDE) study.

Virtual Incision’s MIRA system features a small, self-contained surgical device. Inserted through a single midline umbilical incision in the patient’s abdomen, it allows for complex, multi-quadrant abdominal surgeries. The system also uses existing minimally invasive tools and techniques that are familiar to surgeons. Altogether, MIRA weighs about two pounds.

According to the company, the system’s tray-to-table design could provide the advantages of robotic surgery without requiring them to organize the operating room around the device — a…

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Virtual Incision sends its mini surgical robot to space

This is a screen grab from a NASA broadcast showing a Northrop Grumman Cygnus cargo spacecraft on its way to the International Space Station today (Jan. 30, 2024) with the spaceMIRA from Virtual Incision onboard. [Image courtesy of NASA]Virtual Incision announced today that its MIRA surgical robot system is currently in transit to the International Space Station.

Lincoln, Nebraska–based Virtual Incision in 2022 received a grant for the MIRA platform to be used in a technology demonstration aboard the ISS. The National Aeronautics and Space Administration (NASA) awarded the grant to use the miniaturized robotic-associated surgery (RAS) platform on the 2024 technology demonstration mission.

Today, the company said its spaceMIRA device currently sits aboard a Northrop Grumman Cygnus cargo spacecraft carried by a SpaceX Falcon 9 rocket. It says the robot will assess the impact of zero gravity when performing simulated surgical tasks. During a portion of the experiment…

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Virtual Incision adds $30M in funding for miniaturized surgical robot

[Image from Virtual Incision]Virtual Incision announced today that it added a $30 million extension to its previous $46 million Series C financing round.

The Lincoln, Nebraska-based surgical robot maker announced the initial $46 million raise in November 2021. Current investors Bluestem Capital, Endeavour Vision, Baird Capital, cultivate(MD) Capital Funds and PrairieGold Venture Partners led the round. New health-tech investors Arboretum Ventures and InVivium Capital also joined.

Concurrent with the extension, Virtual Incision appointed Dr. Tom Shehab as a board director and Amy Kobe as a board observer. Shehab serves as managing partner at Arboretum Ventures and Kobe serves as general partner for InVivium Capital.

“We’re grateful for our investors – both existing and new – and are excited to build an even stronger medtech syndicate with the additions of Arboretum and InVivium,” said John Murphy, president and CEO of Virtual Incision. “This financing, parti…

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Virtual Incision submits surgical robot for FDA de novo clearance

[Image from Virtual Incision]Virtual Incision announced that it submitted its MIRA surgical robot to the FDA for de novo clearance review.

Lincoln, Nebraska-based Virtual Incision seeks authorization to market MIRA for use in bowel resection procedures. The submission follows a completed FDA investigational device exemption (IDE) study. FDA approved the IDE supplement for MIRA in April 2022.

MIRA could become the first robot-assisted surgery device to garner de novo clearance for bowel resection procedures. Virtual Incision says this would make it a “trailblazer” in soft tissue robotics. Clearance could also lay the foundations for expanded procedural indications, the company said.

Virtual Incision may look to build on de novo clearance with entry into international markets, the addition of instruments and accessories and the development of future generations for MIRA.

The company plans for a limited launch in the U.S. if it obtains marke…

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16 surgical robotics companies you need to know

Intuitive remains the dominant surgical robotics company, but corporations ranging from Medtronic to Vicarious Surgical look to compete. The Da Vinci Xi robotic surgery system. Intuitive continues to dominate the space. [Image courtesy of Intuitive]Robotic-assisted surgery remains one of the hottest spaces in medtech. Intuitive, which pioneered the field in the 1990s and early 2000s, continues to innovate. At the same time, a host of other companies are looking to compete.

Companies making headlines in the robotic surgery space over the past year include:

Company Robotic system(s) Intuitive Surgical Da Vinci Xi, Da Vinci X, Da Vinci SP, Ion Medtronic Hugo Johnson & Johnson Monarch, Velys, Ottava Stryker Mako Siemens Healthineers’ Corindus CorPath GRX Vicarious Surgical Beta 2 Titan Medical Enos Asensus Surgical Senhance Moon Surgical Maestro Momentus Surgical Anovo Virtual Incision MIRA Stereotaxis Genesis RMN, Vdrive, Niobe Monteris …
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NASA grant will see Virtual Incision’s surgical robot go to space

[Image from Virtual Incision]Virtual Incision announced today that its MIRA platform will be used in a technology demonstration aboard the International Space Station (ISS).

Lincoln, Nebraska-based Virtual Incision received a grant from the National Aeronautics and Space Administration (NASA) to use the miniaturized robotic-associated surgery (RAS) platform on the 2024 technology demonstration mission.

MIRA includes a small, self-contained surgical device inserted through a single midline umbilical incision in the patient’s abdomen, allowing for complex, multi-quadrant abdominal surgeries utilizing existing minimally invasive tools and techniques that are familiar to surgeons.

The platform received IDE approval in October 2020, followed by approval for an IDE supplement in April. In November 2021, Virtual Incision completed a $46 million Series C financing round to support the robotic surgery platform.

It weighs approximately 2 pounds and fits within…

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FDA approves IDE supplement for Virtual Incision’s miniaturized surgical robotics platform

[Image from Virtual Incision]Virtual Incision announced today that it received an FDA investigational device exemption (IDE) supplement for its MIRA platform.

Lincoln, Nebraska-based Virtual Incision’s IDE supplement allows the company to complete the final stage of its clinical study for the MIRA (miniaturized in vivo robotic assistant) platform in bowel resection procedures.

The company said in a news release that the FDA granted the IDE supplement following the reporting of favorable interim clinical study results on the safety profile of the MIRA surgical robotic platform. Results of the completed study following the supplemental approval will support the company’s upcoming FDA de novo application for marketing authorization for the MIRA platform.

MIRA received IDE approval in October 2020. In November 2021, Virtual Incision completed a $46 million Series C financing round to support the robotic surgery platform.

Dr. Michael Jobst and…

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Virtual Incision raises $46M for its miniaturized robotic platform

Virtual Incision is hte developer of the MIRA (miniaturized in vivo robotic assistant) platform. [Image courtesy of Virtual Incision]Virtual Incision announced today that it raised $46 million in a Series C round to support its miniaturized robots for laparoscopic surgery.

The company — based in Lincoln, Nebraska and Pleasanton, California — said the money will fund regulatory and clinical programs supporting the eventual commercialization of its MIRA (miniaturized in vivo robotic assistant) surgical platform.

“Virtual Incision’s goal is to transform surgery by providing a practical and hassle-free platform that will enable efficient, effective and affordable access to robotic-assisted technology, regardless of the site of care,” CEO John Murphy said in a news release.

Endeavour Vision and Baird Capital led the round, with participation from returning investor Bluestem Capital and others..

The company recently announced the first surgery using …

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