OnLume Inc, a medical device company developing novel imaging systems for use during surgery, announces that it had received 510(k) clearance from the US Food & Drug Administration 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 postsurgical complications. The OnLume Imaging System has been demonstrated as safe and effective for these indications via the FDA 510(k) process, according to the company in a media release.
“We are very pleased to have received FDA 510(k) clearance for our clinical imaging system. This clearance is an important step in bringing our vision of fluorescence-guided surgery to market. Our technology gives surgeons key anatomical and functional insights in real-time during surgery, with the goal of improving patient outcomes and reducing healthcare costs,” OnLume CEO Adam Uselmann says in the release.
“Our team is focused on developing a platform that provides clear imaging with ergonomics that are straightforward to integrate into existing surgical workflows. We look forward to expanding to new clinical indications as the field of FGS continues to grow.”
OnLume is performing a limited product launch in Q1 2020, with a nationwide launch planned later this year, it notes.
[Source(s): OnLume Inc, PrZen]