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.

FDA Plans Webinar on Importing Respirators for COVID-19

On Tuesday, June 23, 12:00 pm – 1:00 pm ET, the U.S. Food and Drug Administration (FDA), along with the Centers for Disease Control and Prevention’s (CDC) National Institute for Occupational Safety and Health (NIOSH) and the Occupational Safety and Health Administration (OSHA), will host the second webinar in the webinar series on the topic of Importing Respirators for Health Care Personnel Use during COVID-19 Pandemic.

During this webinar:

  • The CDC’s National Institute for Occupational Safety and Health (NIOSH) will describe respirator testing including the modified filtration efficiency testing NIOSH completes as part of their international respirator assessments.
  • The FDA will speak about the importation of respirators and, with CDC, will speak about their collaboration on the sampling and testing of international respirators in support of the FDA’s respirator Emergency Use Authorizations.
  • Representatives from the FDA, CDC, and OSHA will also respond to questions webinar attendees may have about the safe use of respirators by healthcare personnel during the COVID-19 pandemic.

Hear from speakers, including:

John R. Powers, Jr., Chief, Evaluation and Testing Branch
National Personal Protective Technology Laboratory (NPPTL)
CDC’s National Institute for Occupational Safety and Health (NIOSH)

John Verbeten, Acting Deputy Director
Office of Enforcement and Import Operations
FDA’s Office of Regulatory Affairs (ORA)

We encourage all interested stakeholders to join. Registration is not necessary.




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