medical device guru

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

Cardiovascular / Cardiology

CardioQuip MCH-1000 Earns CE Mark Approval

CardioQuipTM, LLC, a medical device manufacturer focused on development and commercialization of patient temperature control and cardiovascular perfusion technology announced today it has received CE Mark approval for the MCH-1000TM Modular Cooler-Heater SeriesTM. The MCH-1000 Series of cooler-heaters is now available to European...

March 26, 2020

Cardiovascular / Cardiology

VERO Biotech Announces First Patient With COVID-19 Infection Complicating Pulmonary Hypertension Treated with GENOSYL DS, the First and Only FDA-Approved Tankless System for the Delivery of Inhaled Nitric Oxide

VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, today announced that the first patient with COVID-19 infection complicating pulmonary hypertension has been treated with its proprietary inhaled nitric...

March 26, 2020

Orthopedics and Spine

Orthofix Completes Acquisition of FITBONE Limb Lengthening System 

Orthofix Medical Inc., a global medical device company focused on musculoskeletal healing products, today announced it has completed the acquisition of assets associated with the FITBONE® intramedullary lengthening system for limb lengthening of the femur and tibia bones. The transaction also...

March 26, 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

Diagnostics & Healthcare News

EchoNous, Inc. Announces CE Mark Approval for Its Healthcare AI KOSMOS Platform

EchoNous is very pleased to announce that its KOSMOS platform has been approved for CE Markets thanks to the unbending effort of its engineering, operations and regulatory teams. The company’s engineering team has developed a medical tool that, according to physician...

March 24, 2020

Diagnostics & Healthcare News

Nuclein Speeds Commercialization of First Ever Hand-Held PCR Test to Aid in COVID-19 Pandemic 

Nuclein LLC announces plans to expedite the commercialization of its Nuclein™ Hand-Held PCR Test. The company’s disposable, all-in-one, self-test device for infectious disease diagnosis does not require technical expertise and provides battery-powered, sample-to-answer results in under one hour, without the need...

March 23, 2020