The US Food and Drug Administration (FDA) has granted 510(k) clearance to SurgVision’s Explorer Air II device for use with Pafolacianine during intraoperative fluorescence imaging.
Explorer Air II is claimed to be the first product based on SurgVision’s next-generation technology platform.
Marketed by On Target Laboratories under the brand name Cytalux, Pafolacianine is an optical imaging agent used in fluorescence-guided surgery.
Designed to meet the requirements of oncological intraoperative fluorescence imaging, the system will enable real-time imaging during surgery.
The company stated that the system’s prototype has been evaluated for different indications by academic centres.
According to SurgVision, the Explorer Air II can also attain 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.”
The Explorer Air II device previously received approval in the US, as well as a CE mark in the European Union (EU), for visual assessment of blood flow and tissue perfusion.
Part of Bracco Group, SurgVision is a medical technology firm that leverages imaging technologies to enhance outcomes and lower the cost of care.
SurgVision stated that its development pipeline aggregates highly sensitive imaging solutions to visualise tumours during surgical or interventional procedures in real-time, helping in the sensitive and precise detection of tumours.