Medtronic plc, a global leader in healthcare technology, today announced it received CE (Conformité Européenne) Mark for the Harmony™ Transcatheter Pulmonary Valve (TPV) System, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). The Harmony TPV system […]
Coronary/Structural Heart
SandboxAQ’s AQMed Reflects on a Year of Scientific and Technical Achievements
– Developed first-of-its-kind unshielded MCG device for bedside use, published in MDPI Sensors – Presented AI applications in MCG at Frontiers of Cardiovascular Medicine special issue – Breakthrough clinical results on N-STEMI diagnostics presented at AHA Scientific Sessions – Launched…
Microtech Announces First Human Case of Implantable Microsensor for Heart Failure
TEL AVIV, Israel, Dec. 26, 2024 /PRNewswire/ — Microtech, a wholly owned subsidiary of Medinol Inc., a leader in global MedTech research and development, announced that it has initiated human clinical trials of their microsensor platform, in a trial to measure atrial pressures important…
Corvia Medical Achieves CE Certification for Atrial Shunt Under New EU MDR Standards
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®…
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, […]