Activ Surgical has announced receipt of CE Mark approval for its enhanced imaging system, ActivSight Intelligent Light.
The approval of the easy-to-adapt module validates that it meets the requirements of the European Medical Devices Regulation.
Activ Surgical will now be able to commercialise ActivSight across the European Union and other regions where the CE Mark is required.
Designed to be a routine part of surgical practice, ActivSight attaches to existing laparoscopic systems and provides on-demand, real-time surgical insights.
It is said to be the first and only modular form factor with multimodal advanced visualisation for surgeries that are minimally invasive.
A hardware-agnostic module, ActivSight provides surgeons with critical intraoperative visual data and imaging to help improve patient safety and outcomes in the operating room.
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.”
Using ActivSight, surgeons can augment their senses with the help of reality overlays.
Last year, the US Food and Drug Administration (FDA) granted 510(k) clearance for ActivSight, which has already seen clinical use in more than 200 patients and multiple in-human institutional review board (IRB) trials successfully.
Currently, several major US and European hospital networks have been established as pilot sites for the system.