Activ Surgical announced today that it received CE Mark approval for its ActivSight Intelligent Light.ActivSight is an intraoperative imaging module for enhanced surgical visualization.
It is an easy-to-adapt module that attaches to laparoscopic systems. It provides real-time, on-demand surgical insights integrated into standard monitors. In addition, it has multimodal advanced visualization for minimally invasive surgery to access critical intraoperative visual data as augmented reality overlays.
“As an early clinical advisor in the development of ActivSight Intelligent Light, I have seen first-hand the benefits it can provide me and my fellow surgeons in operating rooms around the world,” said Dr. Nicole Bouvy, surgeon and professor at Maastricht University Medical Center (MUMC+) in the Netherlands.
“The system is seamless to use and allows for advanced visualization during surgery, which makes it an important additional tool to potentially reduce surgical complications.”
Activ Surgical is developing an autonomous robotic surgery of soft tissue. ActivSight received FDA 510(k) clearance in 2021. Multiple major hospital networks in the U.S. and Europe have established pilot sites for ActivSight. They’ve used it in over 200 patients and multiple in-human IRB studies.
“The team at Activ Surgical is thrilled to achieve the CE Mark for ActivSight in the European Union and beyond,” CEO Todd Usen said in a news release. “This clearance represents a momentous step forward for the company as we execute against our global commercialization strategy for the system. We believe ActivSight will be a game-changer in the operating room by revolutionizing surgical vision and, ultimately, improving surgical care and patient safety. This is a proud day in Activ Surgical’s history.”