Coronary/Structural Heart

Toku Eyes, Developer of an AI Platform That Accurately Identifies Risk of Heart Attack Using an Eye Image, Expands to The US

With Toku Eyes’ artificial intelligence platform, the eye is not only the window to the soul — it is now a window to the state of your health AUCKLAND, New Zealand , May 31, 2022 /PRNewswire/ — Toku Eyes, the New Zealand-based developer of a multi-modal artificial intelligence platform for instant healthcare diagnostics, today announced […]

Lexicon Resubmits New Drug Application for Sotagliflozin for the Treatment of Heart Failure

THE WOODLANDS, Texas, May 31, 2022 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has resubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of sotagliflozin for the treatment of heart failure. The FDA has a […]

ŌNŌCOR Receives FDA Clearance for Novel Endovascular Retrieval Technology

The ŌNŌ is intended to simplify bailout procedures in the expanding world of structural heart disease interventions PHILADELPHIA, May 25, 2022 (GLOBE NEWSWIRE) — ŌNŌCOR LLC, a leader in endovascular safety technology, today announced it has received 510(k) U.S. Food and Drug Administration (FDA) clearance for its ŌNŌ retrieval system, […]

inHEART RECEIVES FDA CLEARANCE FOR NOVEL 3D CARDIAC MODELING SOLUTION

System creates 3D models of the heart with unprecedented anatomical details, allowing physicians to better plan and personalize therapeutic interventions CAMBRIDGE, Mass. and BORDEAUX, France, May 24, 2022 /PRNewswire/ — inHEART, a privately-held medical device company delivering the world’s most sophisticated digital twin of the heart, announced today that it has received FDA 510(k) clearance […]

Caladrius Biosciences Provides Update on Phase 2b FREEDOM Trial of XOWNA® in Coronary Microvascular Dysfunction

Interim analysis to be conducted following enrollment suspension in the double-blind, randomized, placebo-controlled clinical trial Next development steps for XOWNA® to be announced by year-end 2022 following regulatory and business review Caladrius Management will host a conference call tomorrow, May 24th at 8:15 a.m. EDT BASKING RIDGE, N.J., May 23, 2022 (GLOBE […]

Alnylam Presents New Results from the ILLUMINATE-C Phase 3 Study of Lumasiran in Patients with Advanced Primary Hyperoxaluria Type 1

– Lumasiran Demonstrated Evidence of Improvements in Exploratory Endpoints of Systemic Oxalosis, Including Echocardiographic Structure and Function, Nephrocalcinosis, and Kidney Stone Events – – Expands Upon Previously Reported Reductions in Plasma Oxalate in PH1 Patients with Severe Renal Impairment – CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced new positive […]

V-Wave’s Ventura® Interatrial Shunt: One Year Follow-up from RELIEVE-HF Roll-in Arm Shows Improved Left and Right Ventricular Function in Patients with Advanced Heart Failure

Echo Core Laboratory Data Demonstrates the Potential of a 5-mm Diameter Shunt to Reduce Filling Volumes and Enhance Systolic Function of Both Ventricles, Consistent with Reverse Cardiac Remodeling MADRID, May 23, 2022 /PRNewswire/ — V-Wave Ltd, manufacturer of the V-Wave Ventura investigational interatrial shunt device to help patients with advanced heart failure (HF), […]

Endotronix Announces Positive Data from SIRONA 2 in Late-Breaking Clinical Trial Session

Study met all primary safety and efficacy endpoints for the Cordella™ PA Pressure Sensor System for the treatment of NYHA class III heart failure patients LISLE, Ill., May 23, 2022 /PRNewswire/ — Endotronix, Inc., a digital health and medical technology company dedicated to advancing the treatment of heart failure (HF), today announced positive data […]

Axon Therapies Announces Positive Early Clinical Data from REBALANCE-HF Randomized Clinical Trial

Late-breaking results presented at the European Society of Cardiology’s Heart Failure Association annual conference and simultaneously published online in the European Journal of Heart Failure SANTA CLARA, Calif., May 23, 2022 /PRNewswire/ — Axon Therapies, a private company focused on addressing a root cause of heart failure, today announced positive early results from […]

Evkeeza® (evinacumab) Phase 3 Trial Demonstrates 48% LDL-C Reduction in Children with Ultra-rare Form of High Cholesterol

Children already on other lipid-lowering therapies entered the trial with dangerously high LDL-C (264 mg/dL on average), and 79% saw their LDL-C reduced by at least half at 24 weeks FDA submission planned by end of 2022 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive results from a Phase 3 trial evaluating Evkeeza® (evinacumab) […]