medical device guru

Cardiovascular / Cardiology

FDA Grants Breakthrough Device Designation to Ascyrus Medical Dissection Stent

Ascyrus Medical announced yesterday that it has received Breakthrough Device Designation from the FDA for its Ascyrus Medical Dissection Stent (AMDS) to treat acute Type A aortic dissections. This designation serves as validation of the clinical importance of the AMDS...

August 15, 2019

Cardiovascular / Cardiology

Endotronix Announces FDA Approval to Begin Landmark PROACTIVE-HF Pivotal Trial for Cordella PA Pressure Sensor System

Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure, today announced it has received conditional Investigational Device Exemption (IDE) approval from the U.S. Food and Drug Administration (FDA) to begin the multi-center...

August 5, 2019

Cardiovascular / Cardiology

TransMedics Touts Long-Distance Organ Transport from Hawaii to North Carolina

TransMedics Group, Inc., a medical technology company that is transforming organ transplant therapy for patients with end-stage lung, heart and liver failure, today announced the OCS Lung technology was used in two successful lung transplants using donor lungs from Hawaii...

July 31, 2019

Cardiovascular / Cardiology

MediCool Technologies Welcomes New CEO to Lead Development of Novel AFib Therapy

Electrophysiology Industry Veteran to Lead Early Stage Commercialization MediCool Technologies, an early stage medical device company developing a novel device to painlessly terminate cardiac arrhythmias, today announced that the Company has appointed Mr. Jeff Rynbrandt as President and Chief Executive...

July 10, 2019

Cardiovascular / Cardiology

Materialise Receives FDA Clearance for Cardiovascular Planning Software Suite

Materialise, a global 3D printing software and solutions company, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures. Mimics Enlight is based on...

June 21, 2019

Cardiovascular / Cardiology

Ra Medical Launches Large Registry Trial for Peripheral Laser Device

Ra Medical said today that it launched a large registry study to follow patients treated with its laser device for restenosis in the peripheral arteries. Carldbad, Calif.-based Ra Medical’s Dabra device uses laser radiation ablation to bore through blockages in affected...

June 19, 2019

Cardiovascular / Cardiology

CorMatrix Cor PATCH for Epicardial Tissue Repair Gets FDA Clearance

CorMatrix® Cardiovascular, Inc., a leading developer of regenerative cardiovascular medical devices, today announced FDA 510(k) clearance for the Cor™ PATCH.  The Cor™ PATCH is indicated for epicardial tissue support and repair in adult patients. The Cor™ PATCH epicardial patch is...

June 14, 2019

Cardiovascular / Cardiology

Zoll Buys AED Developer Cardiac Science

Cardiac Science Corporation, a leading provider of automated external defibrillators (AEDs), related services and accessories, today announced it has entered into a definitive agreement to be acquired by ZOLL® Medical Corporation, an Asahi Kasei Group Company that manufactures medical devices...

June 12, 2019

Cardiovascular / Cardiology

ClearFlow Announces Positive Trial Results for PleuraFlow Thoracic Evacuation Device

ClearFlow, Inc., a medical device company based in Anaheim, California, has announced that positive clinical trial results of its PleuraFlow® device were presented at the American Association for Thoracic Surgery (AATS) 99th Annual meeting on May 4 in Toronto, Canada....

May 22, 2019