Posts by cstephenson@legacymedsearch.com
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 Haven Hospital. The Vent Multiplexor is a patent-pending device designed to provide individualized emergency crisis…
Read MoreFDA 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 intended to provide timely access to medical devices that have the potential to provide a…
Read MoreFDA 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 treat this novel virus. Today, we are providing an update on one potential treatment called…
Read MoreCentinel 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 FDA-approved lumbar TDR device that has been clinically reviewed and found safe and effective for…
Read MoreSynapse 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 during the COVID-19 pandemic for no more than 30 days. During the COVID-19 pandemic, the…
Read MoreNew 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 in hospitals and other settings where infection control is urgent. A home version of the…
Read MoreAdvanced 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 in many US hospitals, STERRAD Systems could collectively reprocess millions of compatible N95 respirators daily.…
Read MoreFDA 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 for the patient and staff. “Disposable laparoscopes can reduce hospital costs and prevent cross-contamination between…
Read MoreTack Endovascular System Receives FDA Approval for Below-the-Knee Post-Angioplasty Dissection Repair
Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced it received U.S. Food and Drug Administration (FDA) approval for the Tack Endovascular System (4F), a novel, minimal metal implant for precision dissection repair in the mid/distal popliteal, tibial and/or peroneal arteries. Regulatory approval was based on data from…
Read MoreVomaris 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 alone or inside an existing face mask with the intention of killing viruses and reducing…
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