New FDA Approval Extends Label to Including the i:X’s Detection of Bacteria and Digital Wound Measurement
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.
“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,” said Anil Amlani, MolecuLight’s CEO. “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.”