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Activ Surgical Announces FDA Clearance for ActivSight Intraoperative Imaging Module

Activ Surgical announced the U.S. Food and Drug Administration (FDA) 510(k) clearance of the company’s ActivSight Intraoperative Imaging Module for enhanced surgical visualization.

Metrex Surface Disinfectant Portfolio Secures EPA Approval

The U.S. Environmental Protection Agency (EPA) has approved all eight surface disinfectant products made by an infection prevention leader, Metrex, as effective against SARS-CoV-2, the novel coronavirus that causes COVID-19.

Olympus Supports Safety Actions Regarding Surgical Smoke

Olympus has announced its support of The Joint Commission’s recommended safety actions for managing the hazards of exposure to surgical smoke for health care staff in operating rooms.

Exofin Fusion Redesign Receives FDA Approval

Chemence Medical, a leader in medical cyanoacrylate devices and products, announced the U.S. Federal Drug Administration’s (FDA) 510(k) approval of the company’s redesigned exofin fusion skin closure system.

MolecuLight Inc. i:X Sterile Surgical Sleeve Convenience Kit

MolecuLight Inc. i:X Sterile Surgical Sleeve Convenience Kit

The MolecuLight Inc. i:X Sterile Surgical Sleeve 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.

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 has a U.S. 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 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.

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