Handheld fluorescence imager receives U.S. FDA De Novo clearance
The fluorescence imaging device is optimized for use at the point-of-care, with no requirement to use contrast agents.
MolecuLight (Toronto, ON, Canada) has received U.S. FDA De Novo clearance for its MolecuLight i:X wound fluorescence imaging device, which digitally captures and documents fluorescence information from wounds and surrounding tissue using still images and videos in real time. The device is optimized for use at the point-of-care, with no requirement to use contrast agents.
As reported in multicenter published clinical studies, clinicians used images from the device to inform their wound management practices in real time, in particular, for guided wound sampling, cleaning, and debridement, explains Ralph DaCosta, founder, chief scientific officer, and director of MolecuLight.
The MolecuLight i:X: wound fluorescence imaging device. (Image credit: CNW Group/MolecuLight)
In the U.S., the MolecuLight i:X is indicated as a handheld imaging tool that allows clinicians diagnosing and treating skin wounds at the point of care, to view and digitally record images of a wound, and view and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The device is for prescription use only.
The MolecuLight i:X received a Health Canada Medical Device License in 2015 and a European CE Mark in 2016.
For more information, please visit www.moleculight.com.