medical device guru

Cardiovascular / Cardiology
FDA Approves CVRx’s Neuromodulation Device for Heart Failure
CVRx, Inc., a private medical device company, announced today that it has received Premarket Approval (PMA) from the United States Food and Drug Administration (FDA) to market its BAROSTIM NEO device for heart failure in the United States. The FDA’s Center...
August 19, 2019
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
1 2 3 15