BOSTON– Activ Surgical, a digital surgery pioneer, today announced that it is has received CE Mark approval for its ActivSight™ Intelligent Light (“ActivSight”). The CE Mark validates that ActivSight meets the requirements of the European Medical Devices Regulation, allowing Activ Surgical to commercialize the enhanced imaging system across the European Union and other CE Mark required regions.
ActivSight is an easy-to-adapt module that seamlessly attaches to today’s laparoscopic systems providing real-time, on-demand surgical insights integrated into standard monitors. It is the first and only modular form-factor with multimodal Advanced Visualization for minimally invasive surgery. With ActivSight, surgeons can access critical intraoperative visual data as augmented reality overlays, helping to increase surgical outcomes and patient safety.
“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 Nicole Bouvy, surgeon and professor at Maastricht University Medical Center (MUMC+), 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. I am pleased that Activ Surgical obtained the CE Mark today for ActivSight.”
“Patient safety is my number one priority in the operating room,” said Hans Fuchs, professor of surgery and head of robotic surgery for the department of surgery at the University of Cologne. “Activ Surgical is on the leading edge when it comes to enhancing surgical vision and significantly reducing unintended medical errors, and I am confident that ActivSight will improve surgical outcomes.”
“The team at Activ Surgical is thrilled to achieve the CE Mark for ActivSight in the European Union and beyond,” said Todd Usen, CEO, Activ Surgical. “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.”
Activ Surgical received 501(k)-clearance for ActivSight by the Food and Drug Administration (FDA) in the United States in 2021. To date, multiple major hospital networks across the U.S. and Europe have been established as pilot sites for ActivSight, which has already seen successful clinical use in over 200 patients and multiple in-human IRB studies.
