medical device guru

Cardiovascular / Cardiology

Tack 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...

April 14, 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

Cardiovascular / Cardiology

Abbott’s TriClip Becomes First Device of its Kind to Receive CE Mark for Minimally Invasive Tricuspid Valve Repair

Abbott announced that its TriClip™ Transcatheter Tricuspid Valve Repair System has received CE Mark and is now approved for use in Europe and other countries that recognize CE Mark as a non-surgical treatment for people with a leaky tricuspid valve, a...

April 13, 2020

Cardiovascular / Cardiology

U.S. FDA Grants CytoSorb Emergency Use Authorization for Use in Patients with COVID-19 Infection

CytoSorbents Corporation, a  critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorb® for...

April 13, 2020

Diagnostics & Healthcare News

FDA Grants Breakthrough Device Designation to DNAe’s Sequencing Diagnostic 

DNAe, the next generation sequencing company developing novel diagnostics for use at the point-of-need, today announced that the US Food and Drug Administration (FDA) has granted it a “Breakthrough Device” designation for its pioneering platform and first assay. DNAe has...

April 9, 2020

Diagnostics & Healthcare News

SpiderTech Helping Healthcare Workers Experiencing Irritation, Sores From PPE With Face Protection

In the midst of the COVID-19 pandemic, healthcare workers across the world have been active on social media displaying the painful results of wearing medical personal protective equipment (PPE) for long hours on the job. Face masks, surgical and N95...

April 9, 2020

Cardiovascular / Cardiology

FDA Grants Vapotherm Oxygen Assist Module (OAM) Breakthrough Device Designation

Vapotherm, Inc., a global medical technology company focused on the development and commercialization of its proprietary Hi-VNI® Technology products that are used to treat patients of all ages suffering from respiratory distress, today announced that the U.S. Food and Drug...

April 9, 2020

Diagnostics & Healthcare News

Stryker Releases Emergency Relief Bed, a Limited-Release Medical Bed to Support Critical Needs During Pandemic 

Stryker, one of the world’s leading medical technology companies, announced today it has developed a low-cost, limited-release emergency response bed to quickly aid healthcare providers with efficient care during the COVID-19 pandemic. “People are at the heart of what we...

April 8, 2020

Orthopedics and Spine

Precision Spine Announces the Worldwide Launch of the Reform Ti Pedicle Screw System Providing Surgeons with Increased Flexibility, Versatility, and Visibility 

Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, has launched world wide the Reform® Ti Titanium Pedicle Screw System, which provides surgeons with the increased flexibility, versatility, and visibility that is required during today’s challenging degenerative and trauma spine...

April 8, 2020