US FDA clears i:X handheld wound imaging device

February 5, 2020 0 By FM

MolecuLight Inc has received FDA 510(k) clearance 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 visualisation of fluorescence in wounds and measures wounds and digitally records all images and area measurements.

The image, when used in combination with clinical signs and symptoms (CSS), has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads of >104 CFU/g (colony-forming units per gram) as compared to the examination of CSS alone. 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.

As part of the cleared 510(k) application, results from a 350 patient, 14 site and 20 clinician clinical trial were submitted to the FDA.  This clinical trial demonstrated a three-fold 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 CSS over CSS alone.