medical device guru

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

Biologics, Wound Care, Infection Prevention

BIOLASE Announces Regulatory Clearance of Laser Bacterial Reduction Therapy Indication for Epic Hygiene Laser

BIOLASE, Inc., the global leader in dental lasers, is pleased to announce the Epic Hygiene™ laser received regulatory clearance for Laser Bacterial Reduction (LBR) therapy indication from the Food and Drug Administration (FDA). This new indication now allows for the...

March 25, 2020

Biologics, Wound Care, Infection Prevention

Cynosure Launches Potenza Radiofrequency Microneedling Device Expanding Company’s Growing Skin Revitalization Portfolio

Cynosure, the global leader in medical aesthetics, announced today the U.S. Food and Drug Administration (FDA) clearance of the Potenza™ radiofrequency (RF) microneedling device, the first and only FDA-cleared four-mode RF microneedling device offering clinicians unrivaled versatility and personalized treatments...

February 25, 2020

Biologics, Wound Care, Infection Prevention

RedDress Announces Launch of ActiGraft, FDA-Cleared for the Treatment of Chronic and Acute Wound Types

RedDress, a privately held, Israel and U.S. based company, today announced the U.S. launch of ActiGraft, the first wound treatment that transforms – in real time – a patient’s blood into an autologous whole blood clot tissue. Once applied, ActiGraft serves as...

February 19, 2020

Biologics, Wound Care, Infection Prevention

Advanced Sterilization Products Unveils the Fastest Biological Indicator for Hydrogen Peroxide Sterilization

Advanced Sterilization Products (ASP) announced today it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for a 15-minute time to result on the STERRAD VELOCITY® Biological Indicator (BI)/Process Challenge Device (PCD) for use in STERRAD® Systems.* The 15-minute time...

January 28, 2020