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1st Patients Enrolled in STEM Trial for `Treatment of Chronic Subdural Hematoma

This marks the first patients enrolled in a prospective, randomized, international trial of a liquid embolic agent for the treatment of chronic subdural hematoma (cSDH), a common disease affecting primarily older adults.

Genius AI Detection Receives FDA Clearance – New Deep Learning-based Software Designed to Help Radiologists Detect Subtle Potential Cancers in Breast Tomosynthesis Images

This new technology, represents a pivotal milestone in the early detection of breast cancer, as studies showed Genius AI Detection software aids in the identification and early detection of breast cancer when used with the Genius® 3D Mammography™ exam.

Passio Pump Drainage System Granted 510(k) for Additional Indication for Home Use

The Passio Pump Drainage System consists of the Passio Catheter, a Handheld Control Unit (pump) and a Disposable Collection Kit, which includes a redressing kit, for drainage of recurrent and symptomatic pleural effusion.

Boston Scientific Signs Definitive Agreement to Divest BTG Specialty Pharmaceuticals Business

Boston Scientific notes SERB, backed by private equity firm Charterhouse Capital Partners since 2017, owns a diversified portfolio of prescription medicines focused on rare and life-threatening diseases.

ORTHO Optix Reader Receives CE Mark and Available in Countries That Accept the CE Mark

"The ORTHO Optix Reader allows transfusion medicine labs with smaller testing volumes the same high-quality, consistent results demonstrated from the award-winning, fully automated ORTHO VISION Analyzer," said Bob Stowers, Ortho's head of transfusion medicine product portfolio.

MolecuLight Launches i:X® Sterile Surgical Sleeve for Imaging of Bacteria in Wounds in a Surgical Setting

MolecuLight Inc., the leader in point-of-care fluorescence imaging for real-time detection of bacteria in wounds, announces the launch of its new i:X Sterile Surgical Sleeve Convenience Kit for imaging bacteria in wounds using the MolecuLight i:X in a surgical and/or isolation setting. The convenience kit includes a unique disposable surgical sleeve that is fitted to neatly shroud the i:X device via an adaptor to align the optics of the i:X to the sleeve. It is made of novel, optically-clear material so it doesn’t interfere or degrade the fluorescence signal or image quality of the device. The surgical sleeve is now available to all customer sites in the US and Canada that want to perform bacterial imaging in these clinical settings and enables wound care practitioners to safely use the MolecuLight i:X to image wounds (both standard and fluorescence imaging) in a sterile field by providing a sterile barrier between the i:X device and the patient.

“With the newly available i:X Sterile Surgical Sleeve, our i:X device can now provide critical information of bacterial presence and location in wounds for physicians in the surgical setting”, says Anil Amlani, MolecuLight’s CEO. “With over 900,000 skin graft procedures alone being performed annually in the operating room in the US, we believe there is significant demand for the MolecuLight i:X to inform clinical decision-making for surgeons needing point-of-care diagnostic imaging about the presence of bacteria. Understanding bacterial presence and location is so important to surgeons and enables them to appropriately prepare the wound bed prior to application of costly skin substitutes, which helps to achieve greater treatment success and faster wound healing”1,2.

“The i:X Surgical Sleeve provides a great opportunity for surgeons to fully utilize the diagnostic abilities of the MolecuLight imaging device for wound bed preparation, ensuring the wound bed is appropriate for graft application by repeating imaging after debridement and by allowing targeted and focused debridement revision to ideally maximize graft utilization and outcomes. This procedure provides value, cost efficiency and a high potential to accelerate outcomes”, says Dr. M. Mark Melin, West Campus Medical Director of the Wound Healing Institute at M Health Fairview in Edina, MN. “The MolecuLight Surgical Sleeve ensures surgical field sterility and has broad application for all surgical specialties to enhance detection and management of biofilm and critical bacterial burdens that may otherwise remain undetected and potentiate poor outcomes. I would highly recommend that colleagues trial the sleeve as a part of considering what patient cases would benefit from enhanced evaluation”.

Specific applications for the MolecuLight i:X Sterile Surgical Sleeve in wound care include:

  • Operating room use of the i:X including for cleaning of burn wound, for surgical debridement of wounds, for application of skin substitutes and/or skin grafts, and for vascular surgical applications.
  • Use of the i:X where the device needs to be shielded from the patients such as in a Covid-19 ward or MRSA isolation room. Instead of performing a deep cleaning and disinfection of the MolecuLight i:X between patients, the surgical sleeve can be used instead and can be quickly replaced between patients.
  • Use of the i:X where the device needs to be shielded from a procedure, for example wound ultrasonic debridement where the nature of the procedure causes particles to be airborne.

The MolecuLight i:X procedure (as of July 1, 2020) also has a new US reimbursement pathway that includes two CPT® codes (Category III) for physician work and facility payment for Hospital Outpatient Department (HOPD) and Ambulatory Surgical Center (ASC) settings through an Ambulatory Payment Classification (APC) assignment. These were issued by the AMA and CMS, respectively, after critical review of the large body of supporting clinical evidence and with each body recognizing the medical necessity of this procedure.  These codes were issued by the AMA and CMS, respectively, after critical review of the large body of supporting clinical evidence and with each body recognizing the medical necessity of this procedure.

The i:X Sterile Surgical Sleeve Convenience kit is available through MolecuLight.


Aung B. Can Fluorescence Imaging Predict the Success of CTPs for Wound Closure and Save Costs? Today’s Wound Clinic. 2019

2

Cole W and Coe S. Use of a bacterial fluorescence imaging system to target wound debridement and accelerate healing: a pilot study. J Wound Care. (North American Supplement). 2020
*CPT is a registered trademark of the American Medical Association

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