SILVER SPRING, Md., Feb. 11, 2021 (GLOBE NEWSWIRE) — Aziyo Biologics, Inc. (Nasdaq: AZYO), a commercial-stage regenerative medicine company focused on creating the next generation of differentiated products and improving outcomes in patients undergoing surgery, announced today product design completion for CanGaroo® with antibiotics, the next generation of the Company’s CanGaroo […]
Coronary/Structural Heart
Olatec Therapeutics LLC Announces a Scientific Publication on the Positive Results in the First Known Clinical Trial with a Selective Oral NLRP3 Inhibitor, Dapansutrile, in Patients with Heart Failure
The Phase 1b, randomized, double-blinded, dose escalation, single-center, repeat dose study design assessed the safety and pharmacodynamics with dapansutrile in subjects with stable heart failure with reduced ejection fraction (HFrEF) Antonio Abbate MD PhD, the Principal Investigator, is Professor of Medicine and Medical Director of the Clinical Research Unit at […]
FDA Approves First-in-class Evkeeza™ (evinacumab-dgnb) for Patients with Ultra-rare Inherited Form of High Cholesterol
TARRYTOWN, N.Y., Feb. 11, 2021 /PRNewswire/ — Homozygous familial hypercholesterolemia (HoFH) is an ultra-rare inherited condition that affects approximately 1,300 patients in the U.S. and is characterized by extremely high low-density lipoprotein cholesterol (LDL-C) In pivotal Phase 3 HoFH trial, adding Evkeeza to standard lipid-lowering therapies reduced LDL-C by nearly half at 24 […]
CARMAT Receives FDA Approval to Use the New Version of Its Artificial Heart in the US Early Feasibility Study (EFS)
First enrollment in the study expected in Q1 2021 PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (FR0010907956, ALCAR) (Paris:ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic alternative to people suffering from end-stage biventricular heart failure, today provides […]
First Patient in Europe Treated With Cardiovascular Systems, Inc. Diamondback 360® Coronary Orbital Atherectomy System
ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patient in Europe has been treated with its Diamondback 360® Coronary Orbital Atherectomy System (OAS). Professor Nicolas Van […]
PhysIQ and U.S. Veteran’s Affairs Advance to Interventional Trial Phase
CHICAGO–(BUSINESS WIRE)–physIQ, Inc. and the US Department of Veteran’s Affairs (VA) have advanced their collaboration to address heart failure care to an interventional trial phase. In this next phase, Veterans will be actively monitored so care can be administered in near real-time to avoid or lower the chance of re-hospitalization, […]
SEQUANA MEDICAL LAUNCHES EQUITY PLACEMENT
THIS ANNOUNCEMENT IS NOT FOR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, JAPAN, SOUTH AFRICA OR ANY OTHER JURISDICTION WHERE TO DO SO WOULD BE PROHIBITED BY APPLICABLE LAW PRESS RELEASE REGULATED INFORMATION – INSIDE INFORMATION 9 February 2021, 2:30 pm CET Ghent, Belgium, 9 February […]
Amarin Provides Update on VASCEPA® (Icosapent Ethyl) Regulatory Review Processes in Mainland China and Hong Kong
DUBLIN, Ireland and BRIDGEWATER, N.J., Feb. 09, 2021 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ:AMRN) today announced that its corporate partner in China, Edding, has progressed VASCEPA® (icosapent ethyl) into commencement of the regulatory review processes in Mainland China and Hong Kong. In Mainland China, the Chinese National Medical Products Administration […]
Geisinger researchers find AI can predict death risk
Algorithm using echocardiogram videos of the heart outperforms other predictors of mortality DANVILLE, Pa., Feb. 9, 2021 /PRNewswire/ — Researchers at Geisinger have found that a computer algorithm developed using echocardiogram videos of the heart can predict mortality within a year. The algorithm—an example of what is known as machine learning, or artificial […]
Puzzle Medical Devices Inc. Receives U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for Its Revolutionary Minimally Invasive Transcatheter Heart Pump
MONTREAL, Feb. 8, 2021 /PRNewswire/ – Puzzle Medical Devices Inc., (www.puzzlemed.com) announced today that the U.S. Food and Drug Administration (FDA) has granted the company a Breakthrough Device Designation for its revolutionary transcatheter pump to address heart failure. The FDA Breakthrough Device Program is intended to help patients receive more timely access […]



