TORONTO – The U.S. Food and Drug Administration has granted De Novo clearance to MolecuLight’s i:X wound fluorescence imaging device, allowing the company to expand into the U.S. market. The device digitally captures and documents fluorescence information from wounds and surrounding tissue using still images and videos in real-time. “FDA marketing authorization of the MolecuLight i:X is a monumental milestone for the wound care industry,” said Anil Amlani, CEO of MolecuLight, in a statement. “Thanks to continued clinical studies and 17 publications to date, the clinical evidence is rapidly accumulating that the MolecuLight i:X is a must‑have device in the hands of all wound care clinicians.’’ The MolecuLight i:X received Health Canada Medical Device License in 2015 and European CE Mark in 2016.
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