MolecuLight’s i:X Bacterial Test Receives FDA’s 510(k) Clearance

September 28, 2021

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.  

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