MolecuLight announced that it won FDA 510(k) clearance for its i:X handheld fluorescence imaging device for detecting wounds containing bacteria. MolecuLight i:X is designed to enable real-time point-of-care visualization of fluorescence in wounds, while it measures wounds and digitally records images and measurements. It received FDA de novo clearance in August 2018. The device’s fluorescence […]
moleculight
MolecuLight wins FDA de novo nod for handheld fluorescence wound imager
MolecuLight said yesterday it won FDA de novo clearance for its MolecuLight i:X designed to assess wound surface area and help visualize harmful bacteria within the wounds. The device is designed to improve wound assessments, which are currently made without tools, the Toronto-based company said. The system uses fluorescence to help visualize potentially harmful bacteria […]