medical device guru

Cardiovascular / Cardiology

Cagent Vascular Announces FDA 510(k) Clearance for Balloon Catheter

Cagent Vascular (Wayne, PA), a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its Serranator® PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions. The Serranator device is the first and only...

April 28, 2020

Cardiovascular / Cardiology

FDA Grants ALung Emergency Use Authorization (EUA) to the Hemolung Respiratory Assist System (RAS) for the Treatment of COVID-19 

ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the Company Emergency Use Authorization (EUA) designation to the...

April 27, 2020

Cardiovascular / Cardiology

AliveCor and OMRON Announce Global Strategic Alliance for Comprehensive Remote Cardiovascular Monitoring

AliveCor, a leader in personal ECG products, and OMRON Healthcare, Co., Ltd., a global leader in personal heart health and wellness technology, today announced a global, strategic alliance that combines AliveCor’s ECG technology with industry-leading blood pressure devices from OMRON to...

April 23, 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

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

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

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

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