Synaptive Medical’s Modus X robotic exoscope. Credit: Synaptive Medical/ Globe Newswire.

The US Food and Drug Administration (FDA) has issued 510(k) clearance to Synaptive Medical’s near-infrared (NIR) fluorescence visualisation module, Modus IR.

This enhancement is integrated into the company’s Modus X robotic exoscope, a high-definition digital imaging system equipped with advanced fluorescence capabilities.

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The Modus IR module has already received approval for clinical use in Australia, Canada, and Thailand. It is now available to US healthcare institutions.

The addition of this technology positions Synaptive’s Modus X as a comprehensive tool for neurosurgical, plastic, and ENT surgeries.

Synaptive said the Modus X’s fluorescence feature, powered by custom LED lighting, allows for a live fusion of white light and fluorescence views to help visualise fluorescent tissue and surrounding anatomy simultaneously.

This provides surgeons with additional anatomical context during complex microsurgical procedures.

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The IR mode, which is newly approved, is specifically designed for the visualisation of indocyanine green (ICG) fluorescent dye.

 Synaptive Medical chief strategy officer, president and co-founder Cameron Piron said: “The availability of IR fluorescence is a game changer, making Modus X an unrivalled alternative to traditional surgical visualisation across neurosurgery and beyond.

“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.”

Synaptive said the intraoperative NIR fluorescence visualisation addition, together with its MRI and tractography-enabled neuro-navigation, further enhances the company’s perioperative approach for diagnosing and treating cerebrovascular diseases.

Last year, Synaptive launched its Modus X robotic exoscope system to the European market.