MolecuLight, Toronto, Canada, has received 510(k) clearance from the US Food & Drug Administration (FDA) for its i:X handheld fluorescence imaging device for use in the detection of wounds containing bacteria. The MolecuLight i:X enables real time point-of-care visualization of fluorescence in wounds and measures wounds and digitally records all images and area measurements. Results of the clinical study submitted with the 501(k) application demonstrated a threefold increase in both sensitivity and diagnostic odds ratio in the number of wounds detected as having a bacterial load of >104 CFU/g by use of the MolecuLight i:X in combination with clinical signs and symptoms as compared to examination of clinical signs and symptoms alone. The threefold increase in diagnostic odds ratio, measuring the overall effectiveness of diagnostic tests, was confirmed via microbiology.
The company also announced that per the American Medical Association, the procedure for fluorescence imaging of bacteria will receive a Category lll Current Procedural Terminology code, effective July 1, 2020, which will enable a reimbursement pathway.
In addition to the 510(k), the MolecuLight i:X also has CE marking allowing for its sale in Europe and is approved by Health Canada for sale in Canada.