FDA Clears MolecuLight’s Fluorescence Imaging Device for Bacteria Detection
The FDA has granted 510(k) clearance for MolecuLight’s i:X, a fluorescence imaging device that assesses wounds for bacteria.
The handheld device is used at point-of-care to measure wounds and digitally record images and area measurements. It does not require any contrast agents or contact with the patient, and announces if an antimicrobial product is needed.
The image the device produces is used alongside clinical signs and symptoms to identify wounds that have over a certain amount of colony-forming units of bacteria.