Toronto, Canada– September 23, 2021 – MolecuLight Inc., the creator of a point-of-care fluorescence imaging device 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 methods.1 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 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
Launch of New MolecuLightDX™ Device to Enable Point-of-Care Imaging of Wounds in New Expanding Market Segments
Toronto, Canada– October 14, 2021 – MolecuLight Inc. 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 device.
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 sticker-less measurement capability which automatically measures wound area without the need for wound stickers.
“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 and DX 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 firstname.lastname@example.org.
Joerns Healthcare Introduces Point-of-Care Imaging to Wound Care Portfolio Through MolecuLight Partnership
Charlotte, NC, and Pittsburgh, PA, October 19, 2021 – Joerns Healthcare, a healthcare technology and equipment services company, announces the addition of the MolecuLight i:X® and DX™ wound imaging platforms to its wound management portfolio through an exclusive agreement with MolecuLight Corp. to provide MolecuLight’s fluorescence imaging technology for point-of-care detection of the bacterial burden in wounds. The MolecuLight i:X and DX devices are the first-of-their-kind handheld imaging devices that help clinicians quickly and easily visualize the bioburden of wounds as part of the standard clinical examination. The device can be used on all wounds, in all care settings and provides invaluable information in real-time to inform and support clinician decision-making. The automated wound measurement and assessment platform simplifies wound management to maximize healing and patient satisfaction.
“The revolutionary MolecuLight i:X and DX devices are the first point-of-care devices that simplify wound management and put immediate decision-making data at the clinician’s fingertips. The addition of this bedside imaging tool to our Connexio™ platform creates the first holistic system designed to enable immediate, evidence-based decisions for wound management. The device also eliminates the manual, administrative burden clinicians traditionally face by automating the data flows to their EMR platform of choice. The result is improved healing rates, reduced wound management costs, improved patient satisfaction and increased clinician efficiencies,” says Doug Ferguson, Chief Strategy Officer of Joerns Healthcare.
“We are thrilled to partner with Joerns Healthcare to provide long-term healthcare facilities with access to our imaging platform for their wound care needs”, says Anil Amlani, MolecuLight’s CEO. “In our shared drive to advance the standard of wound care, this new arrangement enables access to what is becoming an essential tool for assisting in clinician decision-making regarding the assessment and treatment of wounds.”
Joerns Healthcare and MolecuLight will partner to deliver comprehensive training (in-clinic, virtual and e-learning) and support programs proven effective by MolecuLight around the globe. To learn more about the MolecuLight i:X and DX, visit www.moleculight.com/.
[ Tratto da: www.woundsource.com ]