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Synaptive Medical Receives FDA 510(k) Clearance for Near-Infrared Fluorescence Visualization, Expanding Application of Existing Robotic Exoscope

Near-Infrared fluorescence now available on Modus X robotic exoscope, complementing system’s existing advanced fluorescence capabilities

TORONTO, March 27, 2024 (GLOBE NEWSWIRE) — Synaptive Medical Inc., a global med tech and technology company solving surgical, imaging and data challenges, 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.

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