SURGVISION'S EXPLORER AIR® II RECEIVES 510(K) CLEARANCE BY THE U.S. FOOD AND DRUG ADMINISTRATION

MUNICH, March 20, 2023 /PRNewswire/ -- 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.

About SurgVision

SurgVision, part of Bracco Group, is a medical technology company with a mission to bring innovation to the imaging space. By leveraging imaging technologies, we are committed to enhancing clinical practice, improving outcomes, and reducing the cost of care.

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures, and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems, and dose-management software. In 2019 Bracco Imaging enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. In 2021, Bracco Imaging established Blue Earth Therapeutics as a separate, cutting-edge biotechnology dedicated to advancing next-generation targeted radiotherapeutics to treat patients who have cancer.

For more information about SurgVision and Bracco Group, please visit www.surgvision.com and www.bracco.com.

¹ Indications for Use in the U.S.: Upon intravenous administration and use of an ICG (Indocyanine green for Injection) consistent with its approved label, the EXPLORER AIR^® II is used in capturing and viewing fluorescent images for the visual assessment of blood flow and tissue perfusion, before, during, and after vascular, gastrointestinal, organ transplant, and plastic, micro- and reconstructive surgeries. The EXPLORER AIR^® II is indicated for use in adult and pediatric patients one month of age and older. Upon administration and use of pafolacianine consistent with its approved labeling, the EXPLORER AIR^® II is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

Indications for Use in the EU: EXPLORER AIR^® II is a fluorescence imaging system used in capturing and viewing fluorescence images for the visual assessment of blood flow for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, reconstructive, gastrointestinal and organ transplant surgeries. The use of EXPLORER AIR^® II is not designated for any specific parts of the body. The exact intended part of the body is defined by surgical application. 

Bracco Imaging Press Office
Duccio Manetti
Global Communications Director
+39 340 9016191
[email protected]

SOURCE SurgVision