FDA 510(k) clearance

TracInnovations Announces FDA Clearance and U.S. Launch of a Markerless Motion Tracking System compatible with Magnetic Resonance scanners from Siemens, GE and Philips.

Copenhagen April 29, 2021 – TracInnovations A/S today announced U.S. Food and Drug administration (FDA) 510(k) clearance of a Markerless Motion Tracking System. This system uses an advanced 3D vision system to monitor, record, and report movements in real time. The system was developed to fulfill clinical requirements in a user-friendly setup, with reliable tracking quality, and high speed motion feedback. Use of the Markerless Motion Tracking System requires minimal additional work from the scan staff.

The Markerless Motion Tracking System creates high quality 3D images from structured invisible infrared light, enabling precision measurement of any movements of a patients head all while supporting a smooth operational workflow andpatient comfort. The Markerless Motion Tracking System is delivered with a TracSuite software package, which has a simple to use Graphical User Interface. A video monitor provides a real time patient image and a digital output continuously of any movement in six degrees of freedom.

“TracInnovations is bringing the first Markerless Motion Tracking System to market with options to support clinicians with state-of-the-art patient imaging and precision motion tracking. In addition the Markerless Motion Tracking System enables, in research environments only, retrospective and prospective correction of motion artifacts in MRI images.” said Dale Flanders, CEO of TracInnovations.

About TracInnovations
TracInnovations A/S is a Danish company established in 2015 focusing on innovative solutions for image based diagnosis and treatment. TracInnovations has developed the Markerless Motion Tracking System, which is a MRI Markerless Motion Tracking and Monitor System using invisible infrared light to measure and record patients head movements during brain scans. The company is focused on collaborating with stakeholders around the world to advance healthcare.