Commercial validation in Europe parallels ongoing RESPONDER-HF clinical trial TEWKSBURY, Mass., Dec. 20, 2024 /PRNewswire/ — Corvia Medical, Inc., a company dedicated to transforming the treatment of heart failure, announced today that it has achieved CE certification for the Corvia®…
Coronary/Structural Heart
FDA Grants IDE Approval for the Pivotal Trial of the JuxtaFlow® Renal Assist Device (RAD)
Roivios Initiates Landmark Study to Demonstrate Safety and Efficacy of an Innovative Renal Assist Device for Cardiac Surgery Patients With Kidney Disease NASSAU, Bahamas, Dec. 19, 2024 /PRNewswire/ — Roivios, a pioneering clinical-stage medical device company dedicated to revolutionizing…
Xentria Announces Exclusive Licensing Agreement with New York University to Advance a Disease-Modifying Cardiovascular Therapy Globally
– Exclusive rights secured related to the development of a potential disease-modifying therapeutic for cardiovascular disease. CHICAGO, Dec. 19, 2024 /PRNewswire/ — Xentria, Inc. (Xentria), a clinical-stage biotherapeutics company focused on advancing drug development to address unmet…
BiVACOR Total Artificial Heart Successfully Implanted in Five Patients as Part of FDA Early Feasibility Study; FDA Greenlights Expansion of the EFS
HUNTINGTON BEACH, Calif.–(BUSINESS WIRE)–BiVACOR, a clinical-stage medical device company, announced today, the successful completion of the first phase of the FDA Early Feasibility Study, with five patients receiving the BiVACOR Total Artificial Heart (TAH) between July and November 2024. The study evaluates the safety and performance of the BiVACOR TAH System […]
Medera’s Novoheart and Curi Bio Partner to Transform Human-Based Cardiac Drug Screening
BOSTON and SEATTLE, Dec. 18, 2024 (GLOBE NEWSWIRE) — Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat or currently incurable diseases with significant unmet needs, today announced that its wholly owned preclinical subsidiary for disease modelling and drug discovery, Novoheart, has entered into a transformative partnership with Curi Bio Inc., a leader in preclinical screening technologies. This strategic collaboration integrates Novoheart’s industry-leading human Heart-in-a-Jar technology with Curi Bio’s advanced Pulse™ analytics platform, delivering an innovative solution for accelerated, high-content, human-based cardiac drug development.
Pulse Biosciences Announces Publication in the Journal of Thoracic and Cardiovascular Surgery
December 17, 2024 08:00 AM Eastern Standard Time MIAMI–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nano-PFA or nsPFA™) technology, today announced a new publication in the Journal of Thoracic and Cardiovascular Surgery. This preclinical study demonstrates the advantages of the […]
First-In-Human Study Demonstrates the Potential of the Reprieve System in Patients with Acute Decompensated Heart Failure
December 16, 2024 08:00 AM Eastern Standard Time MILFORD, Mass. & FRANKFURT, Germany–(BUSINESS WIRE)–Reprieve Cardiovascular, Inc., a development-stage company focused on advancing acute decompensated heart failure (ADHF) treatment, today announced the first-in-human results of the Reprieve System at the CSI Focus D-HF (Device therapies in heart failure) conference in Frankfurt, […]
HeartBeam Announces FDA Clearance for At-Home, High-Fidelity Heart Monitoring Technology
First cable-free, ambulatory ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics Patients can have the credit card-sized device with them at all times, ready to record an ECG whenever they feel symptoms and reduce delays in care Company to initiate […]
ACTION Centers Collaborate with Johnson & Johnson MedTech to Secure FDA Labeling for Impella Support System in Pediatric Patients
CINCINNATI, Dec. 13, 2024 /PRNewswire/ — In a groundbreaking achievement for pediatric heart care, the FDA has expanded the labeling of Johnson & Johnson MedTech’s Impella Support System to include treatment for certain children suffering from heart failure, extending the original…
Genetesis Launches CardioFlux Membership Program to Revolutionize Preventive Cardiac Care and Eliminate Heart Disease
Proactive, personalized monitoring of myocardial fitness at regular intervals, powered by MCG technology, represents paradigm shift in the prevention of heart disease City of Mason’s Biohealth Corridor selected as home of first ever CardioFlux Imaging Institute MASON, Ohio, Dec. 11, 2024…



