medical device guru

Biologics, Wound Care, Infection Prevention

HealthySole HOME Approved to Keep Your Home Safe From COVID-19

Researchers have proven a device using ultraviolet light technology can neutralize the COVID-19 virus and other infectious diseases on the soles of shoes by more than 99.5 percent, according to a new study. The device, called HealthySole® PLUS, is being introduced...

April 28, 2020

Biologics, Wound Care, Infection Prevention

Sterilucent Granted Emergency Use Authorization to Reprocess Respirators

The U.S. Food and Drug Administration has granted Sterilucent, Inc. (Minneapolis, MN), an Emergency Use Authorization to allow the emergency use of the Sterilucent™ HC 80TT Vaporized Hydrogen Peroxide Sterilizer for decontaminating single-use compatible N95 and N95-equivalent respirators. Test results...

April 23, 2020

Biologics, Wound Care, Infection Prevention

New Study Finds HealthySole UVC Technology Deactivates COVID-19 on Footwear

Researchers have proven a device using ultraviolet light technology can neutralize the COVID-19 virus and other infectious diseases on the soles of shoes by more than 99.5 percent, according to a new study. The device, called HealthySole® PLUS, is being introduced...

April 15, 2020

Biologics, Wound Care, Infection Prevention

Advanced Sterilization Products Granted FDA EUA Allowing Decontamination of Millions of Compatible N95 Respirators to Help Protect Against COVID-19

Advanced Sterilization Products (ASP), a Fortive (NYSE:FTV) company and global leader in infection prevention, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the use of STERRAD® Systems to decontaminate compatible N95 respirators.1 Utilizing equipment already available onsite...

April 15, 2020

Biologics, Wound Care, Infection Prevention

Vomaris Seeking Expedited FDA Approval for New Virus-Killing Face Mask 

Vomaris Innovations, Inc., headquartered in Tempe, AZ, announced today that significant research findings confirmed viruses are killed upon exposure to the company’s bioelectric V.Dox™ Technology platform. Vomaris has begun applying their technology to manufacture prototype face masks that can be worn...

April 14, 2020

Biologics, Wound Care, Infection Prevention

Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy

Celularity Inc., a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with...

April 2, 2020

Biologics, Wound Care, Infection Prevention

Battelle Announces Rapid Manufacturing of a System to Decontaminate N95 Respirator Masks

Battelle announced today that it has begun rapid manufacturing of a system to decontaminate N95 respirator masks and other medical protective equipment. Each Battelle CCDS Critical Care Decontamination System™ is capable of decontaminating up to 80,000 masks per day at...

March 30, 2020

Biologics, Wound Care, Infection Prevention

Northwell Implements New On-site Laboratory Treatment Technology for COVID-19 Infected Medical Waste 

To minimize the risk of spreading COVID-19, Northwell Health has become the first US health system to implement a new technology that breaks down medical waste from laboratory testing in a safe, environmentally friendly way. Developed by Irish-based Technopath Clinical...

March 30, 2020

Biologics, Wound Care, Infection Prevention

Biostage Announces IND Approval from FDA for its Lead Product Candidate Cellspan Esophageal Implant

Biostage, Inc., a bioengineering company developing next-generation esophageal implants, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational New Drug application  (IND) for the Cellspan Esophageal Implant (CEI) to treat patients with end-stage esophageal...

March 25, 2020