Surgical navigation and augmented reality company Scopis Medical said today it won FDA 510(k) clearance, as well as Health Canada approval for its next-gen surgical navigation designed for ear, nose and throat surgery.
Cambridge, Mass.-based Scopis designs surgical navigation systems using augmented reality technology, with real-world imaging data enhanced by integrated computer-generated images.
“Scopis currently provides surgical navigational systems with augmented reality for ENT, craniomaxillofacial, spine and neurosurgery procedures in 50 countries worldwide. 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. 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,” CEO & founder Bartosz Kosmecki said in a prepared statement.
The company said its devices are supported by its hybrid navigation platform, based on a small portable unit that supports optical, electromagnetic and simultaneous hybrid packing.
“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,” North America sales VP Karl Ring, who joined the company as part of the launch, said in a press release.