Leica Microsystems receives Class II medical device registration for two of its surgical Augmented Reality accessory solutions

Summary: Leica Microsystems has received medical device licenses from Health Canada for two accessories to its ARveo digital augmented reality surgical microscope solution, which augments the view of blood flow by combining imagery of visible and fluorescent light to provide an augmented view that represents the presence of green dye used in medical diagnostics.

In Augmented Reality News 

September 23, 2020 – Leica Microsystems, a developer and manufacturer of microscopes and a MDSAP certified company, has today announced that it 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 (AR) GLOW800 surgical fluorescence microscope accessory is used in viewing intra-operative blood flow in the brain as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG). In combination with ICG (Indocyanine Green) cyanine dye used in medical diagnostics, GLOW800 allows surgeons to observe cerebral anatomy in natural color, augmented by real-time vascular flow in a single image, with full depth perception, according to Leica Microsystems.

The AR solution provides surgeons with a complete view of anatomy and physiology to support crucial decisions and actions during vascular neurosurgery. The company’s FL800 ULT surgical microscope accessory is also used in similar circumstances.

As a result, Leica states that its solutions can help to reduce interruptions during surgery due to switching between both natural microscope imagery and a flat black and white near infrared video. Instead, the company’s sophisticated imaging sensor and algorithms capture, optimize, and combine multiple spectral bands of visible and fluorescent light. The result is faithful, natural coloring of tissue and accurate representation of fluorescence intensity.

“For the past decade Leica Microsystems has been pioneering new fluorescence imaging technologies in partnership with surgeons to advance surgical practices,” said 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.”

“Leica Microsystems is a company that works closely with neurosurgeons to bring new technologies to market that really respond to our needs,” said 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 has stated that its GLOW800 AR fluorescence is the first of many imaging modalities that will be based on its GLOW AR platform. GLOW AR modalities can be fully integrated in the company’s ARveo digital augmented reality microscope. Following the Class II device registration for GLOW800 by Health Canada, ARveo customers in Canada can now benefit from the advantages of augmented reality visualization in the operating room.

For more information on Leica Microsystems’ augmented reality solutions for surgery, please visit the company’s website.

Image credit: Leica Microsystems

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Sam Sprigg

Sam is the Founder and Managing Editor of Auganix. With a background in research and report writing, he has been covering XR industry news for the past seven years.