The OMNY-AF trial evaluates safety and efficacy of the investigational OMNYPULSE™ Platform, a novel catheter that combines a large ablation area with mapping capabilities Irvine, CA – October 30, 2024 – Today, Johnson & Johnson MedTech, a global leader […]
Rhythm
MedLumics New CEO and Board Member Announces 10 Patients Treated in First in Man (FIM) Clinical Trial With the Real-Time Visually Guided AblaView PFA System
MADRID–(BUSINESS WIRE)–MedLumics, a medical device company developing fiber optically guided platform technologies for the treatment, initially, of Atrial fibrillation (AF), announced today 10 patients treated in the company’s First in Man clinical trial. The AblaView Unipolar Pulsed Field (PF) Ablation […]
Newly Published Research Shows 14-Day Monitoring Detected Almost Three Times More Nonsustained Ventricular Tachycardia Than Standard 48-Hour Monitoring in Patients with Hypertrophic Cardiomyopathy
SAN FRANCISCO, Oct. 28, 2024 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ:IRTC), a leading digital health company focused on creating trusted solutions that detect, predict, and prevent disease, today announced that the results of the Extended Ambulatory ECG Monitoring Enhances Identification of Higher-Risk […]
A new paradigm in electrophysiology: Medtronic receives FDA approval of Affera™ Mapping and Ablation System and Sphere-9™ Catheter
First-of-its-kind, all-in-one HD-mapping and dual energy (pulsed field and radiofrequency) ablation catheter Highly anticipated by electrophysiologists for its innovation and demonstrated safety and efficacy as well as improved workflow and short learning curve Now with two pulsed field…
HeartBeam Named “Rising Star” at the 6th Annual Digital Health Hub Foundation Awards
SANTA CLARA, Calif.–(BUSINESS WIRE)–HeartBeam, Inc. (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care by providing powerful cardiac insights wherever the patient is, announced today its selection as a winner of the 2024 Digital Health Hub Awards, hosted […]
Adagio Medical Announces Completion of First Procedures in FULCRUM-VT U.S. FDA Pivotal IDE of Ventricular Tachycardia Cryoablation System
LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM; “Adagio Medical”, “Adagio” or the “Company”), a leading innovator in catheter ablation technologies, today announced the completion of the first procedures in FULCRUM-VT U.S. Food and Drug Administration (FDA) Pivotal IDE […]
From Battlefields to Connected Care: Avive Solutions and Best Defense Foundation Partner to Protect Veterans with Life-Saving AED Technology
SAN FRANCISCO, Oct. 24, 2024 /PRNewswire/ — Avive Solutions, a leader in advanced cardiac response technology, is proud to announce a meaningful partnership with the Best Defense Foundation, a nonprofit organization dedicated to supporting military veterans. Through this collaboration,…
Boston Scientific Launches Next Generation of Cardiac Mapping for the FARAPULSE™ Pulsed Field Ablation System
New FARAWAVE™ NAV Ablation Catheter and FARAVIEW™ Software combine with OPAL HDx™ Mapping System to provide visualization during pulsed field ablation MARLBOROUGH, Mass., Oct. 18, 2024 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced it has received U.S. Food and…
XYRA Announces FDA Label Guidance for Managing Atrial Fibrillation with Budiodarone and Wearable Monitoring Devices
Key points: Wearable AF monitoring devices are extensively used in routine practice worldwide. The FDA has agreed on the use of AF monitoring devices in clinical trials for budiodarone approval. The FDA has also issued guidance on the steps required to incorporate wearable AF monitoring…
AuriGen Medical Pioneers Next-Generation Atrial Fibrillation Technology with First-in-Human Success
GALWAY, Ireland, Oct. 15, 2024 /PRNewswire/ — AuriGen Medical, a medical device company specializing in left atrial appendage occlusion (LAAO) technology, today announced the successful treatment of their first patient in its first-in-human clinical study. The procedure, performed by Dr…