December 1, 2022

Health Canada Clears Augmented Reality Visualization Solution GLOW800 and FL800 Vascular Fluorescence as Class II Devices

Leica Microsystems receives Class II medical device registration for Augmented Reality GLOW800 Vascular Fluorescence and FL800 Vascular Fluorescence

BUFFALO GROVE, Ill., Sept. 23, 2020 /CNW/ — Leica Microsystems, a MDSAP certified company, has received Class II medical device licenses (GLOW800 #104966 and FL800 ULT #105046) from Health Canada for two surgical microscope accessories.

Leica Microsystem’s augmented reality GLOW800 surgical fluorescence microscope accessory is used in viewing intra-operative blood flow and related tissue perfusion in the cerebrovascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG). In combination with ICG (Indocyanine Green), GLOW800 allows surgeons to observe cerebral anatomy in natural color, augmented by real-time vascular flow in a single image, with full depth perception. This augmented reality solution provides the surgeon a complete view of anatomy and physiology to support crucial decisions and actions during vascular neurosurgery.

Leica Microsystem’s FL800 ULT is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area and bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.

“For the past decade Leica Microsystems has been pioneering new fluorescence imaging technologies in partnership with surgeons to advance surgical practices,” says Markus Lusser, President of Leica Microsystems. “GLOW800 and future modalities based on the GLOW AR platform will allow surgeons to perform life-changing neurosurgical interventions with the confidence that they have the best possible visual information right in the field of view.”

GLOW800 AR fluorescence is the first of many imaging modalities that will be based on the GLOW AR platform from Leica Microsystems. GLOW AR modalities can be fully integrated in Leica’s ARveo digital augmented reality microscope. Following the Class II device registration for GLOW800 by Health Canada, ARveo customers in Canada can now experience the full advantages of augmented reality visualization in the operating room.

“Leica Microsystems is a company that works closely with neurosurgeons to bring new technologies to market that really respond to our needs,” says Cleopatra Charalampaki, Professor of Neurosurgery, Cologne Medical Center, Germany. “GLOW800 AR is an exciting new approach which provides a totally new view during vascular neurosurgery. I have excellent spatial orientation and I am impressed with the crisp delineation of vessels. I believe GLOW800 AR fluorescence will have a significant impact on surgical outcomes in the future.”

About Leica Microsystems

Leica Microsystems develops and manufactures microscopes and scientific instruments for the analysis of microstructures and nanostructures. Widely recognized for optical precision and innovative technology, the company is one of the market leaders in compound and stereo microscopy, digital microscopy, confocal laser scanning and super-resolution microscopy with related imaging systems, electron microscopy sample preparation, and surgical microscopy.

Leica Microsystems has six major plants and product development sites located in Wetzlar and Mannheim (Germany), Vienna (Austria), Heerbrugg (Switzerland), Morrisville (USA), and Singapore. The company is represented in over 100 countries, has sales and service organizations in 20 countries, and an international network of distribution partners. Its headquarters are located in Wetzlar, Germany. Leica Microsystems is part of Danaher.

SOURCE Leica Microsystems

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