TORONTO, Canada – (December 5, 2019) MolecuLight Inc., the world’s leader in handheld fluorescence imaging for real-time visualization of fluorescence in wounds, has received FDA 510(k) clearance for its i:X®handheld fluorescence imaging device for use in the detection of wounds containing bacteria. This FDA 510(k) clearance is an expansion of the original de novo clearance for the MolecuLight i:X platform, granted on August 14, 2018. 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. The i:X’s fluorescence 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 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 alone1. This significant increase in sensitivity was observed consistently across clinical study sites, participating clinicians, wound types and wound sizes. The three-fold increase in diagnostic odds ratio, measuring the overall effectiveness of diagnostic tests, was confirmed via microbiology.
Reference: 1Serena T et al. Presented at SAWC Fall 2019
To learn more about this, please click the PDF or contact:
Chief Marketing Officer