REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner, a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention. The HeartFlow Planner will enable interventional cardiologists to virtually model clinical scenarios vessel-by-vessel, explore treatment strategies […]
Coronary/Structural Heart
Correvio Highlights FDA Acceptance of United Therapeutics’ Trevyent New Drug Application
VANCOUVER, Sept. 12, 2019 /PRNewswire/ – Correvio Pharma Corp. (NASDAQ: CORV) (TSX: CORV), a specialty pharmaceutical company focused on commercializing hospital drugs, today highlighted that the U.S. Food and Drug Administration (FDA) has accepted for review United Therapeutics Corporation’s (NASDAQ: UTHR) New Drug Application (NDA) for Trevyent® (treprostinil) for the treatment of pulmonary arterial hypertension […]
REDUCE FMR Study Shows Cardiac Dimensions’ Carillon® System Significantly Improves Mitral Regurgitation And Slows Worsening Of Heart Failure
KIRKLAND, Wash., Sept. 12, 2019 /PRNewswire/ — Cardiac Dimensions, a leader in the development of innovative, minimally invasive treatments for functional mitral regurgitation (FMR) in patients with heart failure (HF), today announced the publication of the REDUCE FMR clinical study of its Carillon Mitral Contour System®. The Carillon® System is a right heart […]
V-Wave Receives Second FDA Breakthrough Device Designation: Interatrial Shunt for Pulmonary Arterial Hypertension
CAESAREA, Israel, Sept. 12, 2019 /PRNewswire/ — V-Wave Ltd., a privately held medical device company developing novel implantable interatrial shunt devices, today announced that the U.S. Food and Drug Administration (FDA) has granted the company a second Breakthrough Device Designation – the first was for its interatrial shunt for Heart Failure (HF), and […]
MyoKardia to Evaluate Mavacamten as an Alternative to Septal Reduction Therapy in Obstructive Hypertrophic Cardiomyopathy Patients
Planned Study Will Assess Effect of Mavacamten on the Need for SRT Among HCM Patients Referred for Invasive Procedures SOUTH SAN FRANCISCO, Calif., Sept. 10, 2019 (GLOBE NEWSWIRE) — MyoKardia, Inc. (Nasdaq: MYOK), today announced that it will study mavacamten as a therapeutic alternative to septal reduction therapy (SRT). The […]
Occlutech AFR Heart Failure Device Obtains CE Mark Approval
SCHAFFHAUSEN, Switzerland, Sept. 6, 2019 /PRNewswire/ — Occlutech AG announced today that its atrial flow regulator, the Occlutech AFR device, has obtained CE mark approval clearing it for sales on the European CE regulated market. Occlutech AFR is a next generation intra-atrial shunt device, intended to treat heart failure symptoms by decompressing abnormal […]
BIOLIFE4D Becomes First U.S. Company to Successfully Demonstrate Ability to 3D Bioprint a Mini Human Heart
Pioneering biotech company reaches significant milestone, using proprietary bioink to successfully 3D bioprint a mini-heart with full structure of a whole heart, including chambers and ventricles CHICAGO, Sept. 09, 2019 (GLOBE NEWSWIRE) — BIOLIFE4D, a biotech pioneer leveraging advances in tissue engineering to 3D print human organs viable for transplant, today […]
Two new Pfizer-coauthored studies validate Novoheart’s pioneering human bioengineered heart tissues and chambers for improving drug development
September 09, 2019 00:05 ET | Source: Novoheart Holdings Inc. Novoheart seeks to revolutionize human heart tissue engineering for disease modeling and drug discovery Peer-reviewed publications feature results from the completion of two research contracts between Novoheart and Pfizer Novoheart’s proprietary MyHeartTM Platform of human bioengineered heart tissues can represent healthy as well as […]
Recardio’s Phase 2 Regenerative Post-Myocardial Infarction Trial of Dutogliptin Now Enrolling and Recruiting in All Global Centers
Recardio Inc., a life science company developing regenerative therapies for cardiovascular diseases, announced that its Phase 2 study of dutogliptin in combination with filgrastim in early recovery post-myocardial infarction is now enrolling and recruiting in all multiple European and U.S. centers. SAN FRANCISCO, Sept. 9, 2019 /PRNewswire/ — The clinical study is intended […]
Acceleron Receives FDA Orphan Drug Designation for Sotatercept in Pulmonary Arterial Hypertension
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Acceleron Pharma Inc. (NASDAQ:XLRN), a leading biopharmaceutical company in the discovery and development of TGF-beta superfamily therapeutics to treat serious and rare diseases, today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug designation to sotatercept for the treatment of patients with pulmonary […]



