Virtual Incision announced today that it received investigational device exemption (IDE) from the FDA for its MIRA platform.
MIRA, which stands for miniaturized in vivo robotic assistant, is touted by Virtual Incision as a first-of-its-kind miniaturized surgical platform, according to a news release.
Receiving IDE allows Virtual Incision to initiate a clinical study of MIRA across a handful of U.S. hospitals as the company continues to seek out regulatory approval for the platform.
The platform itself 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.
MIRA also does not require a dedicated operating room or specialized infrastructure in tandem with its use and, because of its small size, it is expected to become a cost-effective and accessible option for laparoscopic surgery.
“Because of its clear benefits for patients, the demand for robotically-assisted surgery continues to increase, though challenges still inhibit broader adoption,” Virtual Incision president & CEO John Murphy said in the news release. “MIRA is intended to overcome these limitations, with a simple and cost-effective solution that offers the potential to bring minimally invasive laparoscopic surgery to many more patients. The IDE approval for MIRA is an exciting and critical next step that will allow us to evaluate the safety and effectiveness of this novel device in patients.
“We look forward to working closely with the surgical teams and study sites to advance the MIRA surgical platform with the goal of making minimally invasive surgery more accessible.”