Leica Microsystems receives FDA’s 510(k) clearance for Augmented Reality GLOW800 Fluorescence
Buffalo Grove, USA. Leica Microsystems received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its Augmented Reality GLOW800 Fluorescence. In combination with ICG (Indocyanine Green) GLOW800 enables the observation of cerebral anatomy in natural color, augmented by real-time vascular flow, with full depth perception. The surgeon thus has a complete view of anatomy and physiology to support crucial decisions and actions during vascular neurosurgery.
“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 the Digital Augmented Reality Microscope ARveo which has been launched earlier this year. Following the FDA’s 510(k) clearance, ARveo customers can experience the full advantages of the Augmented Reality visualization now also in the US market.
“Leica Microsystems is a company that works closely with neurosurgeons to bring new technologies to the 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.”
Leica Microsystems develops and manufactures microscopes and scientific instruments for the analysis of microstructures and nanostructures. Ever since the company started as a family business in the nineteenth century, its instruments have been widely recognized for their optical precision and innovative technology. It is one of the market leaders in compound and stereo microscopy, digital microscopy, confocal laser scanning microscopy with related imaging systems, electron microscopy sample preparation, and surgical microscopes.
Leica Microsystems has six major plants and product development sites around the world. 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.
