Virtual Incision, a medical device company pioneering the world’s first miniaturized robotic-assisted surgery platform, says the US Food and Drug Administration has approved an Investigational Device Exemption supplement to complete the final stage of its clinical study analyzing the MIRA Platform in bowel resection procedures.
The approval was supported by a favorable interim clinical study report on the safety profile of MIRA.
The IDE supplement approval puts Virtual Incision on track to obtain the clinical evidence needed to bring innovation to the soft tissue surgical robotics industry, a market that has been historically dominated by a single player. [Read more…] about FDA approves Virtual Incision to complete clinical study enrollment for its MIRA platform