Synaptive Medical’s Near-Infrared Fluorescence Visualization Gains FDA Nod

Synaptive Medical has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its Modus IR near-infrared fluorescence visualization module. The FDA nod adds to the company’s fluorescence offering on its 4K, 3D robotic exoscope, Modus X.
 
Modus IR is already approved for clinical use in Australia, Canada, and Thailand.
 
Synaptive’s Modus X has a fluorescence feature powered by customized LED lighting that allows a live fusion of white light and fluorescence views. This provides visualization of fluorescent tissue and nearby anatomy simultaneously, offering further anatomical context during complex microsurgical techniques.
 
The newly-approved IR mode visualizes indocyanine green (ICG) fluorescent dye, which causes blood to fluoresce under infrared light. This helps visualize vessels and blood flow.
 
Synaptive said adding intraoperative NIR fluorescence visualization in combination with its MRI and tractography-enabled neuro-navigation boosts its perioperative approach to diagnosing and treating cerebrovascular diseases.
 
“The availability of IR fluorescence is a game changer, making Modus X an unrivalled alternative to traditional surgical visualization across neurosurgery and beyond,” said Synaptive Medical’s co-founder, president, and chief strategy officer, Cameron Piron. “The continued development of this platform over the last decade further demonstrates our commitment to pushing the boundaries to develop the best tools to support our clinicians in delivering the best care they can to their patients.”