The FDA IDA approval enables to conduct clinical study of MIRA platform at a limited number of US hospitals
Medical device company Virtual Incision has secured an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to begin the study of its miniaturised in vivo robotic assistant (MIRA) platform.
The IDA approval will enable Virtual Incision to commence a clinical study of MIRA at a limited number of US hospitals, helping to provide a regulatory pathway for the system’s approval.
MIRA is said to be the first-of-its-kind miniaturised surgical robotic support device. It will initially focus on colon resection and later on additional potential applications.
Virtual Incision co-founder and chief medical officer Dr Dmitry Oleynikov said: “Many benign and malignant conditions require removal of a portion of the colon. Currently the most common approach is open surgery, which involves a very large incision, a long hospital stay and several weeks of recovery.”
MIRA platform is composed of a small and self-contained surgical device
The MIRA surgical platform includes a small and self-contained surgical device, which is inserted through a single midline umbilical incision in the patient’s abdomen.
The company’s advanced technology will help conduct complex multi-quadrant abdominal surgeries using existing minimally invasive tools and techniques. It also enables surgeons to avoid the use of a dedicated operating room or specialised infrastructure.
According to the company, the small size of the device makes it to serve as a cost-effective and accessible option for laparoscopic surgery.
Virtual Incision president and CEO John Murphy said: “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.”
In January this year, Virtual Incision secured $20m in a Series B+ financing, led by Bluestem Capital, to advance its miniature surgical robots platform.