Coronary/Structural Heart

CytoSorbents Announces the REFRESH 2-AKI Trial Data Monitoring Committee Has Recommended Study Resumption Following Favorable Review of Safety Data

MONMOUTH JUNCTION, N.J., July 28, 2020 /PRNewswire/ — CytoSorbents Corporation (Nasdaq: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced that the Data Monitoring Committee (DMC) of the REFRESH 2-AKI trial has completed a comprehensive favorable review […]

A startup that monitors heart health with a toilet seat joins Innovators’ Network

Heart Health Intelligence is the latest member of the American Heart Association’s Center for Health Technology & Innovation Innovators’ Network ROCHESTER, N.Y., July 28, 2020 (GLOBE NEWSWIRE) — Heart Health Intelligence (HHI) has joined the American Heart Association’s Center for Health Technology & Innovation’s (the Center) Innovators’ Network. The Center is focused on building and […]

Endonovo Therapeutics Announces Significant Results From Study Showing 70% Reduction of Morphine Equivalent Dose and 2 Day Reduction of Length of Stay at Hospitals Using SofPulse®

LOS ANGELES, July 27, 2020 (GLOBE NEWSWIRE) — Endonovo Therapeutics, Inc. (OTCQB: ENDV) (“Endonovo” or the “Company”), today announced that an investigator initiated study, authored by Dr. Samir Awad, Professor of Surgery at Baylor College of Medicine, entitled ‘The Impact of Pulsed Electromagnetic Field (SofPulse®) on Postoperative Pain in Patients […]

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. […]