Tag: fluorescence imaging

Launch of New MolecuLightDX™ Device to Enable Point-of-Care Imaging of Wounds in New Expanding Market Segments

MolecuLight Platform is Becoming the Standard-of-Care for Real-Time Imaging of Elevated Bacterial Burden in Wounds Across All Wound Care Settings

TORONTO, CANADA – (October 14, 2021) MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of wounds containing elevated bacterial loads, announced the launch of the MolecuLightDX™, a new point-of-care device model targeted at the unique needs of new expanding wound care market segments in the USA. The DX is an expansion of MolecuLight’s product line and compliments the MolecuLight i:X®, the “workhorse” wound imaging device that has quickly become a standard in wound care practices worldwide, with over 2,000 units sold.

“The i:X and DX are the only commercially-available point-of-care devices to enable real-time detection of elevated bacterial burden in wounds. With the introduction of the MolecuLightDX, we are thrilled to expand our product line and provide added functionality for these wound care market segments,” says Anil Amlani, MolecuLight’s CEO.

Specifically, the MolecuLightDX has the following new features frequently required in these segments:

  • Comprehensive EMR (electronic medical record) integration options for multiple EMR environments,
  • Patient-centric user interface and workflow to allow for easy patient and wound tracking,
  • An Administrator workflow and system configuration capability, and
  • Docking system for easier charging of the devive.

As with the i:X, the DX has the same accurate, rapid digital wound measurement for documentation of procedures and of wound progression. Newly available on the DX is a stickerless measurement capability which automatically measures wound area without the need for wound stickers.

Photo Legend: Select new features of the MolecuLightDX include a larger screen (top left), new Stickerless digital wound area measurement for documentation and monitoring of wound progression (top right), and integrated docking station (bottom right). As with the i:X, the DX is used for point-of-care imaging of elevated bacterial burden in wound to help inform clinical decision-making (bottom left).

“With the expansion of our product line, we can now offer clinicians in any care setting the unmatched capabilities of the MolecuLight platform, with a feature set and price point that matches their specific needs”, says Amlani. “MolecuLight customers will continue to receive our comprehensive activation and training support on both platforms, including on-site training with patients, e-Learning courses and certification and ongoing in-person and remote support by our Clinical Applications team.”

In addition, all MolecuLight procedures will be able to benefit from the reimbursement pathway available in the United States for the MolecuLight procedure, which is applicable to both the MolecuLight i:X andDX devices. The reimbursement pathway includes two CPT® codes for physician work to perform “fluorescence wound imaging for bacterial presence, location, and load” and facility payment for Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings through an Ambulatory Payment Classification (APC) assignment.

The MolecuLightDX has received FDA clearance for sale in the USA, as well as the CE Mark and Health Canada approval for commercial availability in Europe and Canada.

The MolecuLightDX will be displayed in the MolecuLight exhibit booth at the upcoming clinical conference, SAWC (Symposium on Advanced Wound Care) Fall 2021, on Sunday, October 31, 2021 at 9:00 am at Caesars Palace in Las Vegas, Nevada. To request an on-site clinical demonstration of the MolecuLightDX, please go to www.moleculight.com, or email info@moleculight.com.

 

About MolecuLight Inc.

MolecuLight Inc., a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight’s suite of commercially released devices, including the MolecuLight i:X® and DX™ fluorescence imaging systems and their accessories, provide point-of-care handheld imaging devices for the global wound care market for the real-time detection of wounds containing elevated bacterial burden (when used with clinical signs and symptoms) and for digital wound measurement. The company is also commercializing its unique fluorescence imaging platform technology for other markets with globally relevant, unmet needs including food safety, consumer cosmetics and other key industrial markets.

 

Rob Sandler
Chief Marketing Officer
MolecuLight Inc.
M. +1.647.362.4684
rsandler@moleculight.com
www.moleculight.com

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

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New FDA Clearance Illustrates the Utility of the i:X to Reliably Predict Pseudomonas aeruginosa, a Bacterial Pathogen that Precludes Wound Healing and Often Evades Conventional Treatment Methods

 

TORONTO, CANADA – (September 23 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 point-of-care detection of wounds containing elevated levels of bacteria. 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.

 

Image and video courtesy of Dot Weir

“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 fluorescence 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 (see image) as well as on the gauze after cleansing, indicating that the wound contains clinically significant (>104 CFU/g) levels of PA:

Video link: https://www.youtube.com/watch?v=X5YiT4zTUL8
References
1 Raizman et al., “Rapid Diagnosis of Pseudomonas aeruginosa in Wounds with Point-of-Care Fluorescence Imaging“, Diagnostics 2021, 11(2), 280

2Turner et al., “Requirements for Pseudomonas aeruginosa Acute Burn and Chronic Surgical Wound Infection”, PLoS Genet. 2014, 10, e1004518

3McManus et al., “Twenty-five-year review of Pseudomonas aeruginosa bacteremia in a burn center”, Eur. J. Clin. Microbiol. 1985, 4, 219–223

 

About MolecuLight Inc.

MolecuLight Inc., a privately-owned medical imaging company that has developed and is commercializing its proprietary fluorescent imaging platform technology in multiple clinical markets. MolecuLight’s first commercially released device, the MolecuLight i:X fluorescence imaging system and its accessories provide a point-of-care handheld imaging device for the global wound care market for the detection of wounds containing elevated bacterial burden (when used with clinical signs and symptoms) and for digital wound measurement. The company is also commercializing its unique fluorescence imaging platform technology for other markets with globally relevant, unmet needs including food safety, consumer cosmetics and other key industrial markets.

 

For more information, contact:

Rob Sandler                                               

Chief Marketing Officer

MolecuLight Inc.
T. +1.647.362.4684

rsandler@moleculight.com

www.moleculight.com

 

Image: Download at: https://moleculight.box.com/s/b4d44tv25dq5wr834ilx7ldiqzl1orxi
Video: https://www.youtube.com/watch?v=X5YiT4zTUL8

Advances in Wound Care Technology: What We See Is What We Get … and More

The science of wound care dressings has progressed a long way over the years, especially during the not-too-distant past. As recently as the early 1990s, the main dressings available to patients included transparent films, hydrocolloids, foam, and calcium alginate. Although not incredibly common, moist wound care was also utilized more than many clinicians would care to admit some 30 years later. Standard dressings at the time were wet-to-dry and betadine.

Today, dressing technology has transitioned from a passive to an active role. Yet, the sophistication of dressings that our patients enjoy today would not be possible without understanding the clinical progression that has occurred, even among those treatments that have since been abandoned … read more

When Should I Perform Point-of-Care Fluorescence Imaging of Wound Bioburden? Guidelines Based on Delphi Consensus

Bacteria and biofilm plague chronic wounds, impair the healing process, and can increase the risk of infection and antibiotic overprescribing. Fluorescence imaging of bacterial burden (MolecuLight i:X) is the only point-of-care solution to visualize the presence of significant bacterial burden in wounds. This information, when added to standard of care, supports informed clinical decision making and more proactive bacterial management practices. This point-of-care imaging technology is quickly becoming a standard in wound care … View webinar start time in your timezone.