Onlume Receives FDA 510(k) Clearance for Fluorescence-guided Surgery Device
OnLume has received 510(k) clearance from the U.S. Food & Drug Administration (“FDA”) to market its first product, a fluorescence guided surgery (FGS) system.
The OnLume Imaging System is indicated for fluorescence imaging of blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, reconstructive, and micro surgeries. This intraoperative imaging technology is used in conjunction with the FDA approved indocyanine green (ICG) dye with applications to several surgical specialties, including cardiac, gastrointestinal, and reconstructive surgery, for identifying regions of poor blood flow that may lead to post-surgical complications. The OnLume Imaging System has been demonstrated as safe and effective for these indications via the FDA 510(k) process.