Surgvision's EXPLORER AIR® II Receives 510(K) Clearance By The U.S. Food And Drug Administration
Tuesday, March 21, 2023
SurgVision, a high-tech company developing pioneering solutions for fluorescence-guided surgical and interventional oncology, part of the Bracco Group, announces that it has received 510(k) clearance from the U.S. Food and Drug Administration for the EXPLORER AIR® II for use with Pafolacianine (CYTALUX, On Target Laboratories Inc.) during intraoperative fluorescence imaging.
This is the first product based on SurgVision's next-generation technology platform. It is designed to achieve high sensitivity and imaging fidelity, meeting the needs of oncological intraoperative fluorescence imaging. The system allows real-time imaging during surgery and its prototype has been tested by academic centers for a variety of indications.
"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," quoted Stefan Schorling, CEO of SurgVision.
The EXPLORER AIR® II is also cleared in the U.S. and CE marked in the EU for visual assessment of blood flow and tissue perfusion.1
Currently, the identification of tumors during surgery or interventional endoscopy relies on visual inspection and palpation. Tumor tissue is sometimes difficult to distinguish from healthy tissue. As a consequence, surgical resection of the tumor is often incomplete. This has medical as well as financial implications, impairing patient treatment outcomes.
SurgVision's response is a development pipeline combining highly sensitive imaging solutions to visualize tumors during surgical or interventional procedures in real-time, enabling a sensitive and accurate detection of the tumor.