Coronary/Structural Heart

VASCEPA® (icosapent ethyl) Data from REDUCE-IT® REVASC, Including New Data on Timeframe to Demonstrated Benefit, Presented as Encore at The American Society for Preventive Cardiology 2020 Virtual Summit on CVD (Cardiovascular Disease) Prevention

VASCEPA showed significant reduction in coronary revascularization, including coronary stenting and cardiac bypass surgery, in prespecified and post hoc analyses of landmark REDUCE-IT study First and total coronary revascularization event reductions of 34% and 36%, respectively, shown with VASCEPA in prespecified tertiary endpoint analyses, with results consistent across different types […]

DalCor announces dal-GenE trial continues with final data expected in the first half of 2021

LONDON and MONTREAL, July 27, 2020 (GLOBE NEWSWIRE) — DalCor Pharmaceuticals today announced that the independent dal-GenE Data and Safety Monitoring Board (DSMB) recommends the dal-GenE pivotal outcomes trial should continue as planned with no modifications. This is an important milestone for DalCor and for cardiovascular patients with the ADCY9 […]

scPharmaceuticals Announces FDA Acceptance of FUROSCIX® New Drug Application Resubmission

FDA sets PDUFA date of December 30, 2020 BURLINGTON, Mass.–(BUSINESS WIRE)–scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that the U.S. Food and Drug Administration […]

MyoKardia Announces Receipt of Breakthrough Therapy Designation from FDA for Mavacamten for the Treatment of Symptomatic, Obstructive Hypertrophic Cardiomyopathy

BRISBANE, Calif., July 23, 2020 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK) today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to mavacamten, a novel, oral, allosteric modulator of cardiac myosin, for the treatment of symptomatic, obstructive hypertrophic cardiomyopathy (HCM).  The FDA’s Breakthrough Therapy […]

Caption Health Receives FDA 510(k) Clearance for Innovation in Point-of-Care Ejection Fraction Evaluation

Latest AI ultrasound tool makes it even easier to automatically assess ejection fraction, a key indicator of cardiac function, at the bedside–including on the front lines of the COVID-19 pandemic BRISBANE, Calif., July 23, 2020 /PRNewswire/ — Caption Health, a leader in medical AI technology, has received FDA 510(k) clearance for an […]

Milestone Pharmaceuticals Announces Regulatory Guidance and Updated Clinical Development Plan for Etripamil in PSVT

– Recently completed NODE-301 and ongoing NODE-301B studies can be used as two efficacy studies supporting a future NDA submission (target p-values of <0.05) – – NODE-301B, renamed the RAPID study, will reopen to enrollment and incorporate a repeat dosing regimen; results anticipated in late 2021/early 2022 – – Proceeds […]

Hancock Jaffe Receives Permission to Proceed with First-in-Human CoreoGraft Study

Patient Selection to Begin Immediately for CoreoGraft Study IRVINE, CA / ACCESSWIRE / July 23, 2020 / Hancock Jaffe Laboratories, Inc. (NASDAQ:HJLI), a developer of medical devices that restore cardiac and vascular health, today announced that Italian Hospital Asuncion in Paraguay has given the Company permission to proceed with the CoreoGraft first-in-human study. […]

Boston Scientific Receives FDA Approval for Next-Generation WATCHMAN FLX™ Left Atrial Appendage Closure Device

New stroke risk reduction technology designed to advance procedural performance and safety, treat wider range of patients with non-valvular atrial fibrillation MARLBOROUGH, Mass., July 21, 2020 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) announced it has received U.S. Food and Drug Administration (FDA) approval for the WATCHMAN FLX™ Left Atrial Appendage Closure (LAAC) Device. Experience […]

RealView Imaging Ltd., the World Leader in Medical Holography, Completes its $10M Series C Funding Round

YOKNEAM, Israel, July 22, 2020 /PRNewswire/ — RealView Imaging Ltd. today announced the completion of its $10M series C financing round. New investors in this round include OurCrowd, a major hi-tech venture capital fund, Judith and Kobi Richter, among the most prominent technology and medical Israeli entrepreneurs, as well as other notable investors and leading physicians. The majority […]

Eko Awarded $2.7 Million SBIR Grant from NIH to Advance Clinical Study on Valvular Heart Disease Detection Using AI and Digital Stethoscope

Ongoing research with Northwestern Medicine to validate algorithms and help more accurately screen for heart murmurs and valvular heart disease during routine office visits OAKLAND, Calif.–(BUSINESS WIRE)–Eko today announced that it has been awarded a $2.7 million Small Business Innovation Research (SBIR) grant by the National Institutes of Health (NIH). The […]