Scopis gets FDA 510(K) and Health Canada MDL clearance for surgical navigation system for ENT surgery
Scopis has received 510(K) clearance from the US Food and Drug Administration (FDA) and Health Canada Medical Device License (MDL) for its breakthrough next-generation surgical navigation products for ear, nose and throat (ENT) surgery.
To support the market launch, the Company also announced that Karl Ring has joined Scopis 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 MDL clearance enables the immediate commercial launch of our innovative ENT-based products in these significant North American markets.”
Mr. Kosmecki added, “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 US 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 Karl Ring, VP Sales North America of Scopis.
Karl Ring joins Scopis as 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, Karl held the position of Director of Market Development, ENT at Smith & Nephew, Inc., 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.
Source: Company Press Release