medical device guru

Cardiovascular / Cardiology

Saranas Launches Early Bird® Bleed Monitoring System in the U.S.

Saranas, Inc. announced the commercial launch of the Early Bird Bleed Monitoring System in the United States. The Early Bird is the first and only device for the monitoring and early detection of endovascular bleed complications through a novel application of bioimpedance sensors....

September 19, 2019

Cardiovascular / Cardiology

FDA Phase 1 Trial Shows Hydrogel to Repair Heart Is Safe to Inject in Humans—A First

Ventrix, a University of California San Diego spin-off company, has successfully conducted a first-in-human, FDA-approved Phase 1 clinical trial of an injectable hydrogel that aims to repair damage and restore cardiac function in heart failure patients who previously suffered a...

September 18, 2019

Cardiovascular / Cardiology

Abbott Wins CE Mark for Pediatric Heart Devices 

Abbott said today that it won CE Mark approval for its Masters HP mechanical heart valve and Amplatzer Piccolo occluder. The Masters HP is the world’s smallest mechanical heart valve (15mm) and is designed for implantation in the mitral or...

September 17, 2019

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