The device received de novo clearance from the FDA back in August of 2018 for fluorescence capture and measurement of wounds, but the new clearance means that it can be used to spot infected wounds. The product is also already approved in the European Union.
“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, 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. 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.”
To prove itself, MolecuLight, the company that makes the i:X device, submitted the results of a study involving 350 patients at more than a dozen clinical facilities. It showed that clinicians evaluating wounds are about three times more likely to detect infected wounds with bacterial loads of more than 104 CFU/g when using the i:X compared with just relying on CSS.
Product page: MolecuLight i:X
Flashbacks: MolecuLight i:X Wound Assessment Tool Now Available in Europe; CE Mark Approval for Moleculight i:X Wound Imaging Device Initiates Product Commercialization in the EU; MolecuLight Coming to U.S. for Easy Fluorescent Imaging of Wounds
Via: MolecuLight
