This 7th FDA clearance further solidifies DiA’s leadership in the ultrasound AI space. BE’ER SHEVA, Israel, Oct. 29, 2020 /PRNewswire/ — DiA Imaging Analysis announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the commercial use of LVivo Seamless for automatic view selection. LVivo Seamless algorithms automatically […]
Coronary/Structural Heart
First Patients Treated with the World’s Smallest Heart Pump, the 9Fr Impella ECP
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces the first two patients have been treated with the Impella ECP expandable percutaneous heart pump. Impella ECP is the smallest heart pump in the world. It measures 9 French (Fr) (3 millimeters) in diameter upon insertion and removal from the body. While in the heart, […]
Pediatric and Congenital Heart Services Expands to Meet Growing Need
Highly specialized pediatric cardiologists join Medical City Children’s Hospital Heart Center DALLAS, Oct. 27, 2020 /PRNewswire/ — To meet the growing need for expert congenital heart care in North Texas, Vivian Dimas, MD, Poonam P. Thankavel, MD, and Ilana J. Zeltser, MD, three highly distinguished pediatric cardiologists, have joined Medical City Children’s Cardiology Specialists. Medical City Children’s […]
Neovasc Announces FDA Advisory Panel Result on Neovasc Reducer™ Medical Device for the Treatment of Refractory Angina
VANCOUVER and MINNEAPOLIS, Oct. 28, 2020 (GLOBE NEWSWIRE) — via NewMediaWire — Neovasc Inc. (“Neovasc” or the “Company”) (NASDAQ, TSX: NVCN) today announced that the United States Food and Drug Administration’s (FDA’s) Circulatory System Devices Advisory Panel voted 14 to 4 “in favor” that the Neovasc Reducer™ is safe when used as intended, and voted 1 to […]
CHF Solutions Announces Deployment of Aquadex Systems to Hospitals in the Southeast to Treat COVID-19 Patients
EDEN PRAIRIE, Minn., Oct. 27, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to changing the lives of patients suffering from fluid overload, today announced that it has shipped Aquadex™ product to medical facilities in Tennessee and South Carolina to treat critically ill patients suffering […]
VALBIOTIS Presents the First Market Data on Untreated LDL-hypercholesterolemia For TOTUM-070, And Announces the Initiation of The Phase II Clinical Study HEART
TOTUM-070 is being developed particularly for individuals with untreated hypercholesterolemia, with LDL-cholesterol levels up to 190 mg/dL associated with moderate overall cardiovascular risk. It responds to an unmet medical need for this population; TOTUM-070 has high potential in the market for non-drug LDL-cholesterol products, which is estimated at 1.2 billion […]
Vascular Care of Texas’ Case Report Published in Vascular Disease Management Showcases Vivify Health’s Remote Patient Monitoring Capabilities
PLANO, Texas, Oct. 27, 2020 /PRNewswire/ — Vivify Health, the developer of the nation’s leading connected care platform for remote patient care, has achieved a new milestone. The use of its remote patient monitoring (RPM) platform to manage care for Vascular Care of Texas’ patients during the COVID-19 pandemic is being highlighted in the October […]
Foldax Receives FDA Approval to Expand Clinical Study of Novel Biopolymer Aortic Heart Valve
SALT LAKE CITY–(BUSINESS WIRE)–Foldax®, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted approval to expand the U.S. clinical study of the Tria™ surgical aortic heart valve. This next stage of enrollment is expected to begin within the next month. “We are excited to expand enrollment […]
Published Peer-reviewed Initial Data from BioCardia Pivotal Phase 3 Clinical Trial of CardiAMP Demonstrates Improvement in Heart Failure Patients Measured by Exercise Outcomes and Cardiac Function
Paper Published in International Journal of Cardiology Demonstrates Safety and Tolerability While Showing Functional Improvement at Six Months SAN CARLOS, Calif., Oct. 26, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA](“BioCardia” or the “Company”), a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today announced the publication of data from the Company’s initial open-label roll-in cohort that served as the […]
VASCEPA® (Icosapent Ethyl) Found to Significantly Reduce Cardiovascular Events in Patients with Compromised Renal Function at Baseline in Prespecified and Post Hoc Subgroup Analyses of Landmark REDUCE-IT® Study Presented at American Society of Nephrology (ASN) Kidney Week 2020
Patients with decreased renal function prior to treatment with VASCEPA or placebo had higher rates of cardiovascular events than the overall population studied in REDUCE-IT REDUCE-IT patients with decreased renal function prior to treatment showed similarly favorable relative risk reductions and numerically greater absolute risk reductions in cardiovascular events in […]



