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Diagnostics & Healthcare News

Brainlab Announces CE Mark for ExacTrac Dynamic Patient Positioning and Monitoring 

Brainlab, the digital medical technology company, today announced CE Mark (Conformité Européenne) approval for ExacTrac® Dynamic, the company’s next generation patient positioning and monitoring system. The new system offers never-before-seen, high-speed thermal surface tracking technology combined with an update of ExacTrac X-ray...

April 21, 2020

Diagnostics & Healthcare News

Vent Multiplexor Receives FDA Emergency Use Authorization for Crisis Care Co-Ventilation During COVID-19 Pandemic

Vent Multiplexor, LLC and Yale New Haven Hospital announced today that the Food and Drug Administration has granted Emergency Use Authorization for the Vent Multiplexor, a life-saving emergency rescue device developed by Vent Multiplexor LLC in collaboration with Yale New...

April 20, 2020

Cardiovascular / Cardiology

FDA Grants NEXUS Aortic Arch Stent Graft System Breakthrough Designation 

Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease was recently granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the NEXUS™ Aortic Arch Stent Graft System. The FDA’s Breakthrough Device Designation Program is...

April 20, 2020

Diagnostics & Healthcare News

FDA Encourages Recovered Patients to Donate Plasma for Development of Blood-Related Therapies

As part of the all-of-America approach to fighting the COVID-19 pandemic, the U.S. Food and Drug Administration has been working with partners across the U.S. government, academia and industry to expedite the development and availability of critical medical products to...

April 16, 2020

Orthopedics and Spine

Centinel Spine Announces FDA Approval for Two-level prodisc L Total Disc Replacement

Centinel Spine®, LLC, the largest privately-held spine company focused on anterior column reconstruction, today announced FDA approval of two-level indications for the prodisc® L Lumbar Total Disc Replacement (TDR) system. Centinel Spine now becomes the only company in the world with an...

April 16, 2020

Cardiovascular / Cardiology

Synapse Biomedical’s TransAeris Diaphragm Pacing System Gets FDA Emergency Use Authorization for Quicker Ventilator Weaning

Synapse Biomedical, Inc. has received an Emergency Use Authorization for the emergency use of its TransAeris® DPS, to assist in weaning patients determined by their healthcare provider to be at high risk of weaning failure off of ventilators in healthcare settings...

April 16, 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

Imaging Visualization & Navigation

FDA Clears New Disposable Fog-Free Articulating 5mm Laparoscope

Xenocor, Inc. announced the FDA cleared the new Xenocor Disposable 5mm Articulating Laparoscope for minimally invasive abdominal and thoracic surgery. The Xenoscope 5mm articulating disposable laparoscope is designed to improve image quality, reduce fog, lower hospital costs, and reduce bio-hazard risk...

April 15, 2020