MolecuLight i:X® Receives FDA 510(k) Clearance for the Device's Ability to Detect Wounds Likely to Contain Pseudomonas aeruginosa (PA)
TORONTO, Sept. 23, 2021 /PRNewswire/ -- MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announces that it has received FDA 510(k) clearance for the detection of wounds containing clinically significant levels (>104 CFU/g) of Pseudomonas aeruginosa (PA) for the previously cleared MolecuLight i:X imaging device. The i:X device visualizes fluorescence, enabling the point-of-care detection of wounds containing elevated levels of bacteria. This new FDA clearance supports the ability of the i:X device to increase the clinician's ability to detect the presence of Pseudomonas aeruginosa in wounds using the cyan fluorescence signal. This augmented labeling is based on a detailed retrospective statistical analysis of over 350 patients.