Canadian medical imaging firm MolecuLight has secured FDA 510(k) approval of its i:X handheld fluorescence imaging device for the detection of wounds with bacteria.

The company said that the FDA has granted 510(k) approval for its i:X platform, following the original de novo approval, awarded in August 2018.

MolecuLight CEO Anil Amlani said: “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. 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. Our clinical study results demonstrate that the i:X used in combination with CSS significantly increases the ability of clinicians to identify wounds with the presence of these bacterial loads when compared with wound assessment based on CSS.”

MolecuLight i:X showed three times increase in diagnostic odds ratio

The MolecuLight i:X is claimed to offer real time point-of-care visualization of fluorescence in wounds and measures wounds and digitally records all images and area measurements.

The fluorescence images produced by the device, when used together with the clinical signs and symptoms (CSS), has been indicated to increase the chances for clinicians to identify wounds with bacteria, compared to CSS examination alone.

The company has submitted results from a clinical trial that involved 350 patients, 14 sites and 20 clinicians, as part of the approved 510(k) application to the FDA.

The clinical study showed that use of MolecuLight i:X, along with CSS, has shown a  three-fold increase in the sensitivity and diagnostic odds ratio in the number of wounds having a bacterial load, compared to CSS alone.

In addition, the increase in sensitivity was consistent across clinical study sites, participating clinicians, wound types and wound sizes, and the three-fold increase in diagnostics odds ratio was confirmed through microbiology.

Apart from the FDA 510(k) approval, MolecuLight i:X has been granted CE mark in Europe and received approval from Health Canada.