FDA recently granted a hand-held imaging device (via the de novo pathway) called MolecuLight i:X. This device allows clinicians to assess, diagnose, and measure wounds by providing real-time imaging of the bacterial distribution with the guidance of fluorescence imaging. Think 'superhero vision'...but for U.S. clinicians! Wound infections are a major cost burden on the health care system and account for increased patient morbidity and prolonged hospital stays. It is estimated that approximately 5.7 million patients in the U.S. are affected with chronic wounds, which comes out to an estimated $20 billion annually.
So, how does the device work? The MolecuLight i:X emits a specific wavelength of violet light, which interacts with wound tissue and potentially harmful bacteria present in the wound (e.g. porphyrins). The wound tissue and surrounding skin emits a green fluorescence, whereas the bacteria present in the wound emits a red fluorescence. The green and red fluorescence are captured in real-time using specialized optical components, and are then displayed on the device screen.
The device can detect fluorescent bacteria at levels of ≥104 colony forming units (CFU)/gram. Clinical studies indicate that MolecuLight i:X can detect common causative organisms associated with wound infections like Staphylococcus aureus/Methicillin-Resistant Staphylococcus aureus (MRSA), Beta-hemolytic Streptococci (Group B), Enterococci, and Pseudomonas aeruginosa. MolecuLight i:X can also detect wound borders and provide wound area measurements. Wound size has traditionally been determined using a wound ruler, which are particularly challenging for irregularly shaped wounds. The device can not only measure wound size and fluorescent bacteria, but it can save those images and track both size and bacteria content over time. This gives clinicians an insight as to how patients are responding to treatment, and whether or not different treatment routes need to be taken.
The device also comes with accessories such as the MolecuLight DarkDrape, which is a high density plastic sheet which can be secured to the patient ensuring appropriate lighting conditions are met when room lights cannot be turned off. Studies showed that MolecuLight i:X-guided treatment significantly increased the rate of wound healing compared with standard of care, and reduced the average closure time of chronic wounds from 200 to 22 days. It's been a while since we've taken a biostatistics class, but that sounds like a pretty favorable recovery time!