MolecuLight, a specialist in handheld fluorescence imaging for real-time visualisation 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 14 August, 2018.
The MolecuLight i:X enables real time point-of-care visualisation of fluorescence in wounds, 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.”
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.
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.
This 510(k) clearance follows recent news that MolecuLight was informed by the American Medical Association (AMA) that in its summary of panel actions from its September 2019 meeting, the CPT Editorial Panel accepted the addition of new Category III codes 0X30T and 0X31T to report “wound bacterial localization and treatment” effective date 1 July, 2020 to enable a reimbursement pathway for point-of-care fluorescence wound imaging.
At that time, a novel code excluding the “X” will be reported by the AMA when the final datafiles are distributed by the AMA. Point-of-care bacterial fluorescence imaging of wounds is achieved using MolecuLight’s handheld fluorescence imaging device, the i:X.