US-based surgical robotics company Virtual Incision has secured an investigational device exemption (IDE) supplement from the US Food and Drug Administration (FDA) for MIRA (miniaturised in vivo robotic assistant) platform.
The approval will allow the firm to complete the final stage of its clinical study analysing the MIRA platform in bowel resection procedures.
FDA’s approval was supported by a positive interim clinical study report on the safety profile of the MIRA surgical robotic platform.
The IDE supplement will put the company on track to gain the necessary clinical evidence for the commercialisation of the device in the soft tissue surgical robotics industry.
MIRA study’s findings will be used to support MIRA’s impending FDA De Novo application for market authorisation.
MIRA’s first user Dr Michael Jobst said: “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.
“MIRA has the potential to bring the benefits of minimally invasive surgery to more patients, and that’s truly exciting.”
Virtual Incision president and chief executive officer John Murphy said: “MIRA was created to address the limitations of traditional robotic-assisted mainframe machines. We miniaturised 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. It is encouraging to see MIRA demonstrating the potential to help surgeons perform simplified robotic procedures safely and precisely.
“Completing the final stage of our clinical study will be a key milestone along MIRA’s regulatory pathway, and we will continue to focus on clinical excellence to best support the innovation we provide to patients and surgeons.”
