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 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 prepa...
Source: Mass Device - Category: Medical Devices Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Wound Care moleculight Source Type: news