Activ Surgical has received a CE mark for its ActivSight Intelligent Light, which allows surgeons to view real-time data while switching between different modes.

ActivSight is an easy-to-adapt module that can be easily attached to currently available laparoscopic systems to provide real-time surgical insights for minimally invasive surgery.

It allows surgeons to access critical intraoperative visual data as augmented reality overlays, and help enhance surgical outcomes and patient safety, said Activ Surgical.

The CE mark approval was granted under the European Medical Devices Regulation (MDR).

It allows Activ Surgical to commercialise ActivSight across the European Union (EU) and other regions that accept the CE mark.

Activ Surgical CEO Todd Usen said: “The team at Activ Surgical is thrilled to achieve the CE mark for ActivSight in the European Union and beyond.

“This clearance represents a momentous step forward for the company as we execute against our global commercialisation strategy for the system.

“We believe ActivSight will be a game-changer in the operating room by revolutionising surgical vision and, ultimately, improving surgical care and patient safety.”

ActivSight is the company’s hardware imaging module that will power its ActivInsights product in future.

As part of the ActivEdge software platform, ActivInsights will use artificial intelligence (AI) and machine learning (ML) technology to produce surgical insights.

Last year, Activ Surgical received the Food and Drug Administration (FDA) 510(k) approval for ActivSight intraoperative imaging module for enhanced surgical visualisation.

The company claims that several major hospital networks across the US and Europe have been using ActivSight as pilot sites.

ActivSight Intelligent Light has already been used for clinical procedures in more than 200 patients and multiple in-human IRB studies.

Maastricht University Medical Centre professor Nicole Bouvy said: “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.

“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.”