MolecuLight’s i:X Bacterial Test Receives FDA’s 510(k) Clearance
MolecuLight has received the FDA’s 510(k) clearance for its MolecuLight i:X imaging device for detection of wounds containing elevated levels of Pseudomonas aeruginosa.
The Toronto, Canada-based company specializes in point-of-care fluorescence imaging for detection of wounds containing elevated bacterial loads. Its MolecuLight i:X previously received 510(k) clearance from the FDA.
P. aeruginosa is a bacterial pathogen that blocks wound healing and often resists conventional treatment methods. The i:X device works by visualizing fluorescence, enabling point-of-care detection of wounds containing clinically significant levels of the pathogen.