MolecuLight i:X® Receives FDA 510(k) Clearance for the Device’s Ability to Detect Wounds Likely to Contain Pseudomonas Aeruginosa (PA)

Friday, September 24, 2021

MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announces that it has received FDA 510(k) clearance for the detection of wounds containing clinically significant levels (>104 CFU/g) of Pseudomonas aeruginosa (PA) for the previously cleared MolecuLight i:X imaging device. The i:X device visualizes fluorescence enabling the detection of wounds containing elevated levels of bacteria in wounds at the point-of-care. This new FDA clearance supports the ability of the i:X device to increase the clinician’s ability to detect the presence of Pseudomonas aeruginosa in wounds using the cyan fluorescence signal.  This augmented labeling is based on a detailed retrospective statistical analysis of over 350 patients.

Pseudomonas aeruginosa (PA) is a common bacterial pathogen that precludes wound healing. PA is notorious for its intrinsic resistance to many antibiotics and its tendency to form biofilm matrices that evade antibiotics and other conventional treatment methods1. The presence of PA in wounds is associated with rapid deterioration and more severe wound outcomes 2,3. The MolecuLight i:X is the only imaging device that provides real-time information on whether a wound is likely to contain elevated levels of PA (>104 CFU/g). The i:X is becoming an essential tool for assisting in clinician decision-making regarding the assessment and treatment of wounds.

“Bacterial removal is a critical component of wound care and wound healing. The ability of the MolecuLight i:X to detect and visualize wounds containing elevated bacterial burden while we are with the patient enables a proactive and objective approach to wound management”, says Dot Weir, RN, CWON, CWS, Clinician at Saratoga Hospital Center for Wound Healing and Hyperbaric Medicine, Saratoga Springs, New York and Co-Chair of SAWC, the Symposium on Advanced Wound Care. “Wounds harboring Pseudomonas often require unique treatments. This new FDA clearance recognizes the added benefit of the i:X in visualizing and differentiating Pseudomonas aeruginosa in wounds through the cyan fluоrescence signal it produces on the images. This is especially important because detecting the presence of Pseudomonas aeruginosa at the point-of-care allows wound care professionals to act immediately to tailor our cleaning, debridement, antimicrobial strategy and treatments accordingly”.

This video showing the cleansing of a diabetic foot ulcer is an example of the MolecuLight i:X’s cyan fluorescence signal indicating the likely presence of PA. The cyan is clearly visible on the patient’s foot as well as on the gauze after cleansing, indicating that the wound contains clinically significant (>104 CFU/g) levels of PA:

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