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CE Mark Approval for Moleculight i:X Wound Imaging Device Initiates Product Commercialization in the EU

September 29th, 2016 Iris Kulbatski Plastic Surgery, Surgery, Vascular Surgery

moleculightMedgadget previously reported on Health Canada’s approval of the wound care imaging device, MolecuLight i:X. Canadian fluorescence image-guidance technology company MolecuLight Inc continues to reach milestones for both the company and the field of wound care. MolecuLight has now been granted CE Mark approval for the MolecuLight i:X Imaging Device, which enables the commercial distribution of this technology in the European Union. The news has been eagerly received by EU clinicians, with the product currently being debuted at the World Union of Healing Societies World Congress being held in Italy between September 25th-29th. Although the device is not currently available in the United States, US FDA de novo approval is pending.

MolecuLight i:X is a point-of-care device that provides real-time fluorescence visualization of infection-causing bacteria without the requirement for contrast agent use.  The device has undergone extensive pre-clinical and clinical testing and has demonstrated safety and efficacy as a tool for wound assessment, diagnosis, and treatment guidance at the bedside.  Through its research, development, and commercialization efforts, the company hopes to enable the widespread use of the device as a standard tool for wound care worldwide.

Here’s a promo video showing off the MolecuLight i:X:

Flashback: Health Canada Approval for MolecuLight i:X Marks Significant Clinical Advancement in Wound Care Diagnosis…

Product page: MolecuLight’s i:X…

Via: MolecuLight…

Iris Kulbatski

Iris Kulbatski (PhD Medical Science, University of Toronto) is a Research Associate and Science Writer, with broad subject matter expertise, including medical devices, stem cell biology, regenerative medicine, cell/tissue bioengineering, cell transplantation, neuroscience, brain and spinal cord injury, spinal cord regeneration, and medical imaging. She has over a dozen peer-reviewed publications, including original research articles, a book chapter, and several review articles. As a biomedical writer and editor for medical device companies, physicians, and scientists, she has developed, written and edited marketing material, technical protocols, educational material, white papers, press releases, promotional material, presentations, web and newsletter content, editorials, e-blasts, manuscripts, abstracts, book chapters, and grant proposals.

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