FDA approves Surgvision’s Explorer Air II device

pharmafile | March 21, 2023 | News story | Medical Communications  

Medical technology company Surgvision has announced that it has received FDA 510(k) approval for its Explorer Air II device. It is indicated for use in adult and paediatric patients aged one month and up.


Currently, the identification of tumours during surgery or interventional endoscopy relies on visual inspection and palpation, however sometimes tumourous tissue is hard to distinguish from healthy tissue. Explorer Air II is an intra-operative imaging system designed for in vivo visualisation of fluorescence in the near-infrared range, revealing tumours during surgery or endoscopy procedures in real-time, which allows for accurate detection.


Explorer Air II was already approved in the US and EU for visual assessment of blood flow and Indocyanine (ICG)-based tissue perfusion, however the approval also now includes the use of Pafolacianine ‒ an optical imaging agent ‒ during intraoperative fluorescence imaging. It is designed to achieve high sensitivity and imaging fidelity.


SurgVision CEO Stefan Schorling said: “We are very excited about this important milestone. Our goal is to make the Explorer Air II available to surgeons supporting them in their mission to fight cancer.”


James Spargo

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