SeaSpine Granted CE Mark for FLASH Navigation

By Julie A. Vetalice

SeaSpine Granted CE Mark for FLASH Navigation

SeaSpine received simultaneous CE Mark certification for its Cranial Module and Percutaneous Spine Module for the 7D FLASH™ Navigation System.

The 7D FLASH Navigation System uses visible light to create a three-dimensional image for surgical navigation in just seconds, resulting in shorter and more efficient spinal and cranial procedures. It is the only regulatory approved image guidance system that utilizes this novel and proprietary camera-based technology, coupled with machine-vision algorithms, to eliminate the long-standing frustrations with legacy surgical navigation platforms. Specific to cranial applications, the FLASH Navigation System uses a completely contactless workflow, acquiring hundreds of thousands of virtual fiducials using the patient’s own anatomy, resulting in nearly instantaneous cranial registrations in almost any surgical position. The speed, accuracy, and efficiency of the FLASH Navigation Machine-Vision technology is intended to provide significant economic value and harnesses the true potential of image guided navigation for spinal and cranial surgery.

Source: SeaSpine

Product Labels: Surgical Navigation

Tags: CE Mark, Regulatory