Synaptive Medical Receives FDA Approval for Modus IR Near-Infrared Fluorescence Visualization Module

Synaptive Medical has received 510(k) clearance from the US FDA for its Near-Infrared fluorescence visualization module, Modus IR, which is used for visualization of indocyanine green (ICG) fluorescent dye, adding to the existing fluorescence offering on its 4K 3D robotic exoscope, Modus X.

Already approved for clinical use in Australia, Canada, and Thailand, 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 availability of IR fluorescence is a game changer, making Modus X an unrivalled alternative to traditional surgical visualization across neurosurgery and beyond,” said Cameron Piron, Chief Strategy Officer, President and co-founder of Synaptive Medical.

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.

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