Synaptive Medical receives FDA 510(k) clearance for NIFV

Synaptive Medical Inc. has received 510(k) clearance from the Food and Drug Administration (FDA) for its Near-Infrared fluorescence visualization module, Modus IR, adding to the existing fluorescence offering on its 4K 3D robotic exoscope, Modus X.

Already approved for clinical use in Australia, Canada, and Thailand, Synaptive’s Modus IR is now available to healthcare institutions in the United States and bolsters the complete offering of Synaptive’s exoscope for use across all neurosurgical procedures, as well as in plastic and ENT surgery.

Synaptive’s Modus X features a unique fluorescence feature, powered by customized LED lighting, that enables a live fusion of white light and fluorescence views. This enables visualization of fluorescent tissue and surrounding anatomy simultaneously to provide additional anatomical context while performing complex microsurgical techniques.

The newly approved IR mode is used for visualization of indocyanine green (ICG) fluorescent dye. ICG causes blood to fluoresce under infrared light and is used to aid in the visualization of vessels and blood flow.

“The availability of IR fluorescence is a game changer, making Modus X an unrivalled alternative to traditional surgical visualization across neurosurgery and beyond,” commented Cameron Piron, Chief Strategy Officer, President and co-founder of Synaptive Medical. “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.”

The addition of intraoperative NIR fluorescence visualization, in combination with Synaptive’s MRI and tractography enabled neuro-navigation, enhances Synaptive’s perioperative approach to diagnosis and treatment of cerebrovascular diseases.
MB Bureau