Therapy Areas: Devices
Robotic-Assisted Surgery Specialist Virtual Incision Completes FDA Investigational Device Exemption Clinical Study of MIRA
24 February 2023 - - US-based medical device company Virtual Incision Corp., which is in the development of the world's first miniaturized robotic-assisted surgery system, has completed its US Food and Drug Administration Investigational Device Exemption clinical study, the company said.

The study was designed to evaluate the company's MIRA Surgical System for use in bowel resection procedures.

This is an important achievement towards bringing new technologies to hospitals and their surgical robotics programs regardless of the site of care.

The surgical cases were completed at three hospitals across the country. Patients who participated in the study were followed after their procedure to fulfill study requirements.

The complete data will be correlated and submitted to the FDA as part of the company's De Novo request for market authorization.

Virtual Incision is the first RAS developer to complete a US IDE study to support a De Novo request in bowel resection.

There are 5m Americans who undergo abdominal soft tissue procedures annually, however, more than 90% go without access to RAS.

If authorized by the FDA, MIRA's miniaturized, strong, and easy-to-use design could potentially increase the overall availability of RAS.

It has the potential to integrate into any facility or operating room by serving as a complement to the existing mainframe RAS systems, or by expanding into new sites of care and geographies as a standalone.

Virtual Incision aims to increase patient access through a clinically, operationally, and economically sound platform available to all providers.

MIRA is the world's first miniaturized robotic-assisted surgery system. Its small, sleek design is planned to offer the benefits of RAS during bowel resection procedures without the logistical inefficiencies of traditional mainframe robotics.

The easily accessible device weighs approximately two pounds and offers internal triangulation with shoulders, arms, and infinite wrist roll inside of the body. It can be used in any operating room a dedicated mainframe room is unnecessary.

With its drape- and dock-free design and portability, MIRA is quick to set up, clean up, and move between cases, the company said.

Its accessible design positions it to be used as a standalone system or a complementary tool for facilities that already own a mainframe.

Virtual Incision is on a mission to simplify robotic-assisted surgery, so more patients and their surgeons can access its benefits every day.

Headquartered in Lincoln, Nebraska, and holding over 200 patents and patent applications, the company is developing MIRA, the first-of-its-kind miniature RAS platform. Virtual Incision's goal is to make every operating room RAS-ready.