MolecuLight announced that it won FDA 510(k) clearance for its i:X handheld fluorescence imaging device for detecting wounds containing bacteria.
MolecuLight i:X is designed to enable real-time point-of-care visualization of fluorescence in wounds, while it measures wounds and digitally records images and measurements. It received FDA de novo clearance in August 2018.
The device’s fluorescence image, along with clinical signs and symptoms, has been shown to increase the likelihood of clinicians identifying wounds containing bacterial loads of >104 CFU/g (colony-forming units per gram) when compared to examining the clinical signs and symptoms alone, according to a news release.
MolecuLight said part of its 510(k) clearance includes results from a 350-patient, 14-site clinical trial that demonstrated a three-fold increase in both sensitivity and diagnostic odds ratio in the number of wounds in which the bacterial loads were detected with MolecuLight i:X when compared to clinical signs and symptoms alone.
The Toronto-based company said its MolecuLight i:X also has CE Mark approval in Europe and is approved by Health Canada for sale in Canada as well.
“The granting of our 510(k) clearance by the FDA for the i:X handheld fluorescence imaging device is very exciting and is a further validation of the growing clinical evidence supporting the utility of our imaging platform,” MolecuLight CEO Anil Amlani said in the release. “Bacteria at loads of 104 CFU/g have been shown to delay wound healing, resulting in poor patient quality of life and high wound care costs worldwide. Identifying wounds with bacterial loads of >104 CFU/g at the point-of-care enables the clinician using the MolecuLight i:X to provide more appropriate, targeted treatment.