medical device guru

Cardiovascular / Cardiology
FDA Grants EBR Systems Breakthrough Device Designation Status for the WiSE Cardiac Resynchronization Therapy (CRT) System 
EBR Systems, Inc., developer of the world’s only wireless cardiac pacing system for heart failure, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the WiSE CRT System for the treatment of heart...
September 11, 2019
Cardiovascular / Cardiology
Tivus Ultrasound System for Pulmonary Arterial Hypertension Gets FDA Breakthrough Designation
SoniVie, an Israeli company developing a novel system for the treatment of PAH, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the Therapeutic Intra-Vascular Ultrasound (TIVUS) System in patients...
September 10, 2019
Cardiovascular / Cardiology
Pacemaker-Like Implant Cleared in Europe to Lower Blood Pressure
Orchestra BioMed™, Inc., (“Orchestra BioMed” or the “Company”), a biomedical innovation company providing high-impact solutions for large unmet needs in procedure-based medicine, announced today that it has received CE Mark approval for its Moderato® implantable pulse generator system that delivers BackBeat...
September 5, 2019
Cardiovascular / Cardiology
First-ever: FDA Clears Biobeat’s Wearable Watch and Patch for Non-invasive Cuffless Blood Pressure Monitoring
Biobeat, a bio-medical technology company developing advanced sensing and remote monitoring solutions for patients, announced today that the U.S. Food and Drug Administration (FDA) has granted a 510K clearance for its patch and watch for measurement of blood pressure, oxygenation and...
August 29, 2019
Cardiovascular / Cardiology
Miracor’s Heart Attack Device Secures FDA Breakthrough Status
The concept of pressure-controlled intermittent coronary sinus occlusion, abbreviated to PICSO, has been around since the 1980s. PICSO entails placing a device in the coronary sinus to intermittently obstruct blood flow. Through the interference, PICSO may increase blood flow to parts of...
August 23, 2019
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
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