The US Food and Drug Administration (FDA) has authorised the marketing of Virtual Incision’s MIRA Surgical System, a miniRAS device, for adult colectomy procedures.
Featuring a compact size, the MIRA Surgical System weighs less than one kilogram, and its tray-to-table setup could make robotic surgery more accessible.
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Virtual Incision president and CEO John Murphy announced the FDA’s decision, which came through the De Novo Classification process.
Murphy said: “Today marks a turning point in surgical robotics as we have hit a significant milestone in making miniaturised robotic surgery a reality.
“Whether as a complement to the existing mainframes or as a stand-alone platform, miniaturisation has the potential to accelerate the adoption of robotic-assisted surgery.”
The authorisation was partially based on results from the US Investigational Device Exemption (IDE) clinical study carried out by the company.
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By GlobalDataVirtual Incision chief medical officer Piet Hinoul said: “Data from our IDE clinical study demonstrated that MIRA can successfully be used to mobilise the colon in a minimally invasive way.
“Starting with a difficult multi-quadrant procedure like a colectomy presents an exciting opportunity for us to address a high unmet need before we expand into other indications.”
The system is designed for quick OR readiness, potentially transforming any space into a robotic surgery suite within minutes.
Virtual Incision plans to initiate MIRA’s commercialisation through a First Access Programme in selected US centres, with a phased production increase and expansion to additional sites.
The company’s future road map for MIRA includes applications in gynaecology, general surgery, urology and other soft tissue surgeries.
Studies for gynaecological procedures are scheduled for this year, and a new version tailored for general surgery is expected to be trialled internationally later this year.
Recently, Virtual Incision said its surgical mini robot was making its way to the International Space Station to assess zero-gravity impacts on surgery.
