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Scopis, a company specializing in surgical navigation and medical augmented reality, announced today that it has received 510(K) clearance from the U.S. 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. 

“Scopis currently provides surgical navigational systems with augmented reality for ENT, craniomaxillofacial, spine and neurosurgery procedures in 50 countries worldwide,” says 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.”

(Image credit: Scopis video)

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 variety of surgical procedures across different disciplines. The modularity and versatility of this powerful platform also permits interdisciplinary use.

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