June 30, 2020 — DiA Imaging Analysis, a leading provider of advanced AI-based solutions for ultrasound analysis, announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) 510(k) and a European CE mark for two additional AI-powered ultrasound analysis solutions.

June 30, 2020 — A new study shows that SARS-CoV-2, the virus that causes COVID-19 (coronavirus), can infect heart cells in a lab dish, indicating it may be possible for heart cells in COVID-19 patients to be directly infected by the virus.

June 30, 2020 —  BioCardia, Inc. announced that the company has resumed cases in the CardiAMP Heart Failure Trial. The first patient procedure completed since elective procedures were paused due to COVID-19 took place at Morton Plant Hospital in Clearwater, Florida this month. New consents have also taken place at additional centers. 

June 29, 2020 — Boston Scientific received U.S. Food and Drug Administration (FDA) 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor (ICM) System, a new, long-term diagnostic device implanted in patients to detect arrhythmias associated with conditions such as atrial fibrillation (AF), cryptogenic stroke and syncope.

June 29, 2020 — A type of smart magnetic resonance imaging (MRI) scan used in people with heart disease could help assess whether children's cancers are especially aggressive and spot early signs that targeted treatments are working, a new study suggests.

June 26, 2020 — Abbott announced new data from the company's LightLab Initiative that showed optical coherence tomography (OCT) imaging significantly changes how physicians decide to treat a vessel compared to traditional angiography by providing physicians improved visualization within a patient's blood vessels. Data from the study revealed physicians altered their treatment strategy in 88 percent of coronary artery blockages based on new information provided by OCT.

June 26, 2020 – New data from the Global SYMPLICITY Registry (GSR) showed that renal denervation (RDN) with the Medtronic Symplicity Renal Denervation System significantly reduced blood pressure (BP) in uncontrolled hypertension patients out to three years independent of anti-hypertension medication burden. The data were presented virtually as part of the PCR e-Course 2020 this week. 

June 23, 2020 – Heart valve start-up Foldax is looking to reinventing several aspects of the prosthetic heart valve, from material used, design and use of robotic manufacturing, announced the closing of a $20 million Series D round of funding.

June 23, 2020 — Philips announced the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the company’s HeartStart FR3 (models 861388 and 861389) and HeartStart FRx (model 861304) automated external defibrillators (AEDs), and their supporting accessories, including batteries and pads.

June 23, 2020 — The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Program status for the preCardia catheter-based system for treating volume overload in patients with acutely decompensated heart failure (ADHF). 

Subscribe Now