Virtual Incision Announces Approval to Complete Clinical Study Enrollment for its MIRA® Platform

FDA decision supported by an interim clinical study report on patient safety

Lincoln, Neb. – April 19, 2022 – Virtual Incision Corporation, a medical device company pioneering the world’s first miniaturized robotic-assisted surgery (RAS) platform, today announced the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) 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. Results of the completed study will support MIRA’s upcoming FDA De Novo application for market authorization.

Click here to read the remainder of the press release as published on the Company’s website, or click here to view a PDF version.

Shared by Steve Kirby, board member of Virtual Incision Corporation.