FDA grants IDE supplement for first miniaturized robotic-assisted surgery platform
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Virtual Incision Corp. announced FDA approval of an Investigational Device Exemption supplement for its final stage clinical study of the MIRA Platform for bowel resection procedures.
According to a company press release, MIRA is the first-of-its-kind, miniaturized robotic-assisted surgery (RAS) platform, which offers the benefits of RAS without the inefficiencies of traditional robotics. The platform received favorable interim trial safety profile reports.
“MIRA was created to address the limitations of traditional robotic-assisted mainframe machines,” John Murphy, president and CEO of Virtual Incision, said in the release. “We miniaturized and simplified MIRA to make it more accessible, easy to use and easy to adopt. These are the features that will allow surgeons to treat more patients each day.”
One of the first surgeons to operate with MIRA, Michael A. Jobst, MD, of Bryan Medical Center in Nebraska, added, “Our clinical experience has been extremely positive so far. I was able to perform 100% of the dissection with MIRA in all of my cases. We have also been pleased with its accessibility and efficiency. I operated on eight patients in five different operating rooms, and that’s something that’s just not possible with mainframe RAS platforms.”
Final stage clinical study results will support Virtual Incision’s upcoming FDA De Novo application for market authorization.
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