Scopis Receives FDA 510(K), Health Canada MDL Clearance for Surgical Navigation System

Scopis, a company specializing in surgical navigation and medical augmented reality, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Health Canada approval for its next-generation surgical navigation products for ear, nose and throat (ENT) surgery. To support the market launch, the company has hired Karl Ring as vice president of sales in North America.
 
“Scopis currently provides surgical navigational systems with augmented reality for ENT, craniomaxillofacial, spine and neurosurgery procedures in 50 countries worldwide,” said Bartosz Kosmecki, CEO and founder of Scopis. “Receiving both FDA 510(K) and [Health Canada] clearance enables the immediate commercial launch of our ENT-based products in these significant North American markets. We are excited to welcome Karl, a highly-experienced sales executive in our sector, to lead our commercialization efforts in North America. Operating from our new location in Cambridge, Massachusetts, we are well-prepared to enter these markets.”
 
Scopis designs surgical navigation systems that use augmented reality (AR) technology, where real-world imaging data from the surgical environment is enhanced by integrating computer-generated images. Scopis’ next-generation Target-Guided Surgery Systems (TGS) lead a surgeon along mapped-out pathways directly to anatomical targets using AR-generated images overlaid onto the surgeon’s endoscopic view.
 
The heart of the Scopis technology is the premium Hybrid Navigation platform that is based on a small and portable unit that supports optical, electromagnetic and simultaneous hybrid tracking. It allows surgeons to choose the best-suited technology for a variety of surgical procedures across different disciplines. The modularity and versatility of this powerful platform also permits interdisciplinary use.
 
“With my experience in the U.S. market, specifically in the ENT space, I’m confident that this breakthrough technology in surgical navigation will have a substantial impact on the ENT community and patients. I am looking forward to bringing these products to surgeons performing sinus procedures in both hospital and office-based settings,” said Ring.
 
Ring is a seasoned expert in the fields of sales, marketing and business development for medical devices, including those specifically for ears, nose and throat. Most recently, he held the position of director of market development, ENT at Smith & Nephew plc., where he also provided strategic consulting for transactions dealing with business and sales development. Prior to that, he held similar roles, ranging from business development international, at ENTrigue Surgical to vice president of sales and marketing at Biotronic NeuroNetwork and regional sales positions with Medtronic ENT.
 
Scopis develops medical augmented reality (AR) and Hybrid Navigation, creating solutions for the healthcare market, including technology for surgical education and planning and navigation systems for otorhinolaryngology (ENT), craniomaxillofacial (CMF), spine and neurosurgery. In more than 50 countries worldwide, surgeons have performed more than 10,000 surgeries with the aid of Scopis’ products and have benefitted from the highly-advanced image guidance and visualization capabilities of Scopis’ technology.