MolecuLight, a Toronto, Canada firm, won FDA de novo clearance for its MolecuLight i:X device that can photograph and video record the fluorescence of serious wounds and nearby tissues. The device can capture both regular light images as well as images taken when the scene is illuminated with an excitation light. No contrast agents are required to use the MolecuLight i:X.
While natural light lets one see the wound, it doesn’t reveal the bacterial activity going on within. Fluorescence imaging can expose groups of bacteria present on the wound, and therefore guide a more targeted treatment regimen.
“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” said Dr. Ralph DaCosta, Founder, Chief Scientific Officer, and Director of 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 sampling1, cleaning2 and debridement2. We’re very excited that US clinicians will soon have the same access to this device as their peers in Canada and Europe.’’
Here’s a video that shows off the MolecuLight i:X:
Flashbacks: MolecuLight i:X Wound Assessment Tool Now Available in Europe…; CE Mark Approval for Moleculight i:X Wound Imaging Device Initiates Product Commercialization in the EU…; Health Canada Approval for MolecuLight i:X Marks Significant Clinical Advancement in Wound Care Diagnosis…
Via: MolecuLight…
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