The U.S. FDA has granted Toronto-based medical imaging company MolecuLight, Inc. clearance to market its groundbreaking wound-fluorescence-imaging device. The device digitally captures and documents fluorescence information from wounds and surrounding tissue using still images and videos in real-time, and is optimized for use at the point of care without the need for contrast agents.
“The MolecuLight i:X platform is a significant advancement in the management of chronic wounds, that is already revolutionizing wound care practice in Canada and Europe,” says Ralph DaCosta, MD, founder, chief scientific officer and director for MolecuLight Inc.
“Thousands of patients to date have already experienced a change in their assessment and treatment by clinicians who feel empowered by the wound fluorescence images they are seeing. As reported in multi-centered published clinical studies, clinicians used the images to inform their wound-management practices in real-time, in particular, for guided wound sampling, cleaning, and debridement,” DaCosta says. “We’re very excited that US clinicians will soon have the same access to this device as their peers in Canada and Europe.”
The marketing authorization from FDA “is a monumental milestone for the wound care industry” adds Anil Amlani, CEO of MolecuLight Inc. “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.”
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 also view and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. It is designated for prescription use only. The company received its Health Canada Medical Device License in 2015, and the European CE Mark for the device in 2016.