Entries by jeremiah

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Virtual Incision Announces Publication of Data from its U.S. Investigational Device Exemption Study in the Clinical Journal, Diseases of Colon and Rectum

 – Data demonstrate the safety and efficacy of the MIRA Surgical System, a novel miniaturized robotic-assisted surgery device, in adults undergoing colectomy procedures LINCOLN, Neb. – April 30, 2024 – Virtual Incision Corporation, the developer of the MIRA™ Surgical System (MIRA), today announced data from its Investigational Device Exemption (IDE) clinical study has been published in […]

Virtual Incision to Showcase Miniaturized Robotic-Assisted Surgery at SAGES 2024

-MIRA, the world’s first miniaturized robotic-assisted surgery device, will make its debut at the national conference for gastrointestinal and endoscopic surgeons   – Scientific program includes four presentations that highlight Virtual Incision’s technology, including one-year follow-up of the cancer patient cohort from the U.S. Investigational Device Exemption clinical study  LINCOLN, Neb. – April 10, 2024 – […]

Virtual Incision Receives FDA Authorization for the MIRA Surgical System as the First Miniaturized Robotic-Assisted Surgery Device

– New category challenges industry standards in soft tissue robotic-assisted surgery and has the potential to expand access to minimally invasive care – De Novo premarket review pathway establishes initial indication for adults undergoing colectomy procedures and lays the foundation for expansion into other abdominal procedures   LINCOLN, Neb. — February 24, 2024 — Virtual Incision Corporation […]

Virtual Incision’s Miniaturized Surgical Robot En Route to the International Space Station for Testing of Long-Range Remote Capabilities

spaceMIRA becomes the first surgical robot on the Space Station through partnership with the University of Nebraska and NASA LINCOLN, Neb. and CAPE CANAVERAL, Fla. — January 30, 2024 — Virtual Incision Corporation, the developer of the MIRA Surgical System (MIRA), today announced that spaceMIRA is currently in transit to the International Space Station. The device […]

Virtual Incision Extends Series C Round with Additional $30M Funding

  Investment will accelerate advancements of the MIRA Surgical System LINCOLN, Neb. – September 19, 2023 – Virtual Incision Corporation, the developer of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced a $30 million extension to its previous $46 million Series C financing. The round was led by current investors Bluestem Capital, Endeavour Vision, […]

Virtual Incision Announces MIRA’s Clinical Trial Results Will Be Presented at the 2023 ASCRS Scientific Meeting

Attendees will be the first to see outcomes from the complete patient series within MIRA’s Investigational Device Exemption clinical study LINCOLN, Neb. – May 31, 2023 – Virtual Incision Corporation, the developer of the world’s first miniaturized robotic-assisted surgery (RAS) system, today announced that the data from its Investigational Device Exemption (IDE) clinical trial will be […]

The MIRA Surgical System Proceeds to FDA Substantive Review for Market Authorization Under the De Novo Classification Pathway

Virtual Incision Has Achieved a Significant Milestone in Its De Novo Request and is Closer to Potential Commercial Readiness  Lincoln, Neb. – May 18, 2023 – Virtual Incision Corporation today announced its De Novo request was submitted and is under substantive review by the U.S. Food and Drug Administration (FDA). The submission seeks authorization to market ​the MIRA […]

Disclosure and Important Safety Information

The MIRA Surgical System is intended for prescription use only. Patients should talk to their doctor to decide if surgery with a MIRA Surgical System is right for them. Patients and doctors should review all available information on nonsurgical and surgical options and associated risks in order to make an informed decision.

Serious complications may occur in any surgery, including minimally invasive surgery with the MIRA Surgical System, up to and including death. Serious risks include, but are not limited to, injury to tissues and organs, and/or conversion to other surgical techniques which could result in a longer operative time and/or complications.

For important safety information, including surgical risks and considerations, please also refer to www.virtualincision.com/safety-information. For the product’s indications for use, risks, full cautions, and warnings, please refer to the associated user manual(s).

Individual outcomes may depend on a number of factors, including but not limited to patient characteristics, disease characteristics, surgeon, and/or hospital experience.

MIRA Surgical System Precaution Statement

The demonstration of safety and effectiveness for the representative specific procedures was based on evaluation of the MIRA Surgical System as a surgical device and did not include evaluation of outcomes related to the treatment of cancer (overall survival, disease-free survival, local recurrence) or treatment of the patient’s underlying disease/condition. Device usage in all surgical procedures should be guided by the clinical judgment of an adequately trained surgeon.

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