pursuing a 510(k) clearance from the FDA. The company intends to eventually market its system for use in procedures on humans, but Uselmann says that the regulatory burden is lower with animals, and that selling to veterinary surgeons would allow OnLume to collect user feedback and start bringing in revenue before devoting more attention to the clinical approval process.
Uselmann says that OnLume’s device is designed to be compatible to image any fluorophore during surgery. There are some fluorophores that specifically target cancerous cells, but all are currently in clinical trials, he says. Uselmann expects one or more of them to be approved for human use by the time OnLume’s device reaches the market.
