Virtual Incision Corporation has recently announced the approval of the MIRA™ Surgical System by the U.S. Food and Drug Administration (FDA). The MIRA system is recognized as the world’s first miniaturized robotic-assisted surgery (miniRAS) device, specifically intended for use during colectomy procedures in adults. This regulatory approval was obtained through the FDA’s De Novo Classification process, a rigorous pathway used to classify novel medical devices lacking a current legally marketed predicate.
The MIRA system addresses these challenges with its compact, approximately two-pound framework, designed to be portable and quick to set up. Its unique "in-a-tray" form factor allows for easy integration into operating rooms without requiring dedicated space or extensive setup procedures. Virtual Incision plans to introduce the MIRA system through its First Access Program in selected centers across the United States, with plans for further expansion into additional surgical specialties.
Minimally invasive surgery (MIS) has revolutionized surgical care by reducing pain, complications, and recovery time through smaller incisions. Robotic-assisted surgery has further advanced MIS by providing surgeons with enhanced precision and control, particularly for complex procedures. Despite these benefits, the adoption of robotic surgery remains limited in many U.S. operating rooms due to logistical challenges and high costs.
The MIRA Surgical System represents a significant advancement in robotic-assisted surgery. Its compact design and versatility make it a valuable tool for a wide range of surgical procedures, offering enhanced precision and efficiency while minimizing logistical barriers. With the MIRA system, Virtual Incision aims to make robotic-assisted surgery more accessible and practical for healthcare facilities and patients alike.
Source: https://www.businesswire.com/news/home/20240224929002/en/Virtual-Incision-Receives-FDA-Authorization-for-the-MIRA-Surgical-System-as-the-First-Miniaturized-Robotic-Assisted-Surgery-Device
