Sam Brusco, Associate Editor12.06.22
Digital surgery pioneer Activ Surgical has procured a CE mark approval for its ActivSight intelligent light, an easy-to-adapt module that attaches to laparoscopic systems to allow real-time, on-demand surgical insights integrated into standard monitors.
According to the company, it’s the first and only modular form factor with multimodal advanced visualization for minimally invasive surgery. Using ActivSight surgeons can access critical intra-op visual data as augmented reality overlays to increase outcomes and 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,” Nicole Bouvy, surgeon and professor at Maastricht University Medical Center (MUMC+), told the press. “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,” added 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.”
ActivSight earned U.S. Food and Drug Administration (FDA) 510(k) clearance in 2021. The technology has already seen successful clinical use in over 200 patients and multiple in-human IRB studies.
According to the company, it’s the first and only modular form factor with multimodal advanced visualization for minimally invasive surgery. Using ActivSight surgeons can access critical intra-op visual data as augmented reality overlays to increase outcomes and 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,” Nicole Bouvy, surgeon and professor at Maastricht University Medical Center (MUMC+), told the press. “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,” added 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.”
ActivSight earned U.S. Food and Drug Administration (FDA) 510(k) clearance in 2021. The technology has already seen successful clinical use in over 200 patients and multiple in-human IRB studies.