The FDA has recently given 510(k) clearance MolecuLight i:X, a handheld device that uses fluorescent light imaging to detect infected wounds. This clearance expands upon the de novo clearance that the technology was granted on August 14, 2018. MolecuLight i:X allows users to utilize real-time point-of-care visualization of fluorescence in wounds while measuring and digitally recording all images and readings.
When used in combination with clinical signs and symptoms (CSS), i:X’s fluorescence image has been shown to increase the physician’s ability to identify wounds with bacterial concentrations above 104 CFU/g (colony-forming units per gram), in comparison to the examination of symptoms alone. Moleculight i:x has received CE marking for European sales and is approved by Health Canada as well.
“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,” noted Anil Amlani, MolecuLight’s CEO, in a press release. “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.
MolecuLight received this clearance after submitting the results from a 350 patient, 14 sites and 20 physician clinical trials to the FDA. This study showed that the use of MolecuLight i:X and CSS together resulted in a three-fold increase in both sensitivity and diagnostic odds ratio in the number of wounds identified as having a bacterial load over 104 CFU/g compared to just using CSS alone. This jump in sensitivity was seen consistently in various clinical study sites and amongst an array of doctors analyzing wounds of diverse types and sizes. Microbiology confirmed the three-fold increase in diagnostic odds ratio, which measured the overall effectiveness of the diagnostic tests.
In other recent news surrounding MolecuLight, the company was recently told by the American Medical Association (AMA) that in its summary of panel actions from its September 2019 meeting, the CPT® Editorial Panel accepted to add the new Category III codes 0X30T and 0X31T to report “wound bacterial localization and treatment. ” This is designed to enable a pathway for reimbursement for point-of-care fluorescence wound imaging and will be effective on July 1, 2020, at which point the novel code excluding the “X” will be reported by the AMA once the final data are distributed.
“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,” said Amlani.