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 which may other be missed.
The device won indications from the FDA as a handheld imaging tool that allows for the diagnosis and treatment of skin wounds at the point of care. The system also allows for the viewing and digital recording of wounds traditionally and through fluorescence emitted images of wounds exposed to an excitation light.
“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. 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. We’re very excited that US clinicians will soon have the same access to this device as their peers in Canada and Europe,” founder & chief scientific officer Dr. Ralph DaCosta said in a prepared statement.
“FDA marketing authorization of the MolecuLight i:X is a monumental milestone for the wound care industry. 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,” CEO Anil Amlani said in a press release.
Last December, Smith & Nephew (NYSE:SNN), which distributes for MolecuLight, said it launched the MolecuLight i:X handheld imaging device in Europe.