Coronary/Structural Heart

HeartFocus Launches First Clinical Product in the U.S. With Butterfly Network

BORDEAUX, France–(BUSINESS WIRE)–HeartFocus, the revolutionary, AI-enabled cardiac imaging software developed by data-driven medtech company DESKi, today announced its U.S. commercial launch. HeartFocus will initially be available on Butterfly Network’s handheld ultrasound devices, the FDA-cleared software enables any healthcare professional to conduct diagnostic-quality heart ultrasounds after just hours of training. Health […]

Otsuka Medical Devices Receives Manufacturing and Marketing Approval for Paradise Ultrasound Renal Denervation System for the Treatment of Resistant Hypertension First in Japan

TOKYO–(BUSINESS WIRE)–Otsuka Medical Devices Co., Ltd. (“Otsuka Medical Devices”) announced that the Paradise™ Ultrasound Renal Denervation (uRDN) system has received approval for manufacturing and marketing in Japan for the treatment of resistant hypertension on August 25. This marks the first approval in the country for a medical device indicated for […]

Catheter Precision Receives Notification of New Patent Issuance for VIVO Product Line

Fort Mill, S.C., Aug. 25, 2025 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (VTAK – NYSE/American), a US based medical device company focused on developing technologically advanced products for the cardiac electrophysiology market announced that it has received notification from the Unites States Patent and Trademark Office for issuance of a new a VIVO patent titled Methods of Ventricular Arrhythmia Localization Using a 3D Heart Model. This patent is in addition to several already granted patents for VIVO.

REPATHA® NOW INDICATED FOR ADULTS AT INCREASED RISK FOR MAJOR ADVERSE CARDIOVASCULAR EVENTS DUE TO UNCONTROLLED LDL-C

THOUSAND OAKS, Calif., Aug. 25, 2025 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has broadened the approved use of Repatha® (evolocumab) to include adults at increased risk for major adverse cardiovascular events (MACE) due to…

OneMedNet Adds 2.7M Annual Cardiovascular Studies, Expanding Network

MINNEAPOLIS, Aug. 20, 2025 (GLOBE NEWSWIRE) — OneMedNet Corporation (Nasdaq:ONMD) (“OneMedNet” or the “Company”), a leader in AI-powered Real-World Data (RWD), announced the addition of 85 cardiovascular centers and data sources, expanding its Cardiovascular network thereby positioning OneMedNet as one of the largest providers for Cardiovascular Real-World data. Cardiovascular diseases (CVDs) remain the world’s leading cause of death, responsible for approximately 19.8 million deaths in 2022, accounting for roughly 32% of all global mortality1. Economically, the burden is staggering: CVD drives an estimated $320 billion annually in the United States alone, and more than $1 trillion globally each year in direct healthcare costs and lost productivity2. Such pervasive health and financial pressures make OneMedNet’s enriched multimodal cardiovascular data network ideally suited for pharmaceutical and insurance sectors. For drug developers, this real-time, expansive data offers deeper insights into disease progression, treatment responses, and outcomes—fueling more efficient, evidence-based R&D and accelerating the development of novel therapeutics. This expansion enhances OneMedNet’s network, delivering de-identified cardiovascular imaging, diagnostic reports, and electrocardiograms (ECG) at unprecedented scale and clinical depth to life sciences companies, AI developers, and medical device manufacturers, with data that is continually updated to reflect the latest clinical insights and advancements. The addition of these new sites solidifies OneMedNet’s position as the premier source for high-quality, regulatory-grade cardiovascular RWD, fueling innovation, supporting clinical evidence generation, and improving patient outcomes through the most robust ecosystem in the industry. “By combining de-identified cardiovascular imaging, structured reports, and ECG signals from this vast network, we’re providing real-world clinical insights that accelerate innovation in diagnostics, therapeutics, and AI model development. This is the clinically rich, longitudinal data the industry has been demanding—and we’re delivering it at scale, with continual updates ensuring the most current and relevant information,” said Aaron Green, President and CEO of OneMedNet. World Health Organization Cardiovascular Disease – https://www.who.int/news-room/fact-sheets/detail/cardiovascular-diseases-%28cvds%29World Heart Federation 2025 Report – https://world-heart-federation.org/resource/world-heart-report-2025/ About OneMedNet Corporation OneMedNet is revolutionizing how the world unlocks Real-World Data (RWD), harnessing the untapped potential of over 1,750 healthcare sites through its iRWD™ platform. This isn’t just data—it’s the lifeblood of innovation, from de-identified medical imaging to electronic health records, fueling breakthroughs for drugmakers, medical device pioneers, and AI visionaries. With a network spanning rare diseases, oncology, cardiology, and beyond, OneMedNet delivers precision insights that redefine patient care and power the next wave of healthcare disruption. Beyond healthcare OneMedNet’s proprietary AI anonymizes data for industries like finance, retail, and telecom, unlocking endless possibilities—rigorously testing production system upgrades, de-risking complex projects, and securely sharing sensitive data by stripping out personal information. Learn more at www.onemednet.com. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. We base these forward-looking statements on our current expectations and projections about future events, which we derive from the information presently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as “may,” “should,” “expects,” “anticipates,” “contemplates,” “estimates,” “believes,” “plans,” “projected,” “predicts,” “potential,” or “hopes” or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of OneMedNet; our ability to keep pace with new technology and changing market needs; the competitive environment of our business; risks inherent with investing in Bitcoin, including Bitcoin’s volatility; and our ability to implement our Bitcoin treasury strategy and its effects on our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. We undertake no obligation to update publicly any forward-looking statements for any reason after the date of this press release to conform these statements to actual results or to changes in our expectations. OneMedNet Contacts: Michael Wong, VP Marketing Email: michael.wong@onemednet.com

CORRECTION – Bringing Advanced Vascular Diagnostics to the Western US with the SmartVascular Dx™ Test

IRVINE, Calif., Aug. 19, 2025 (GLOBE NEWSWIRE) — MorningStar Laboratories, LLC., (“MSL” or “the Company”), a leading developer of precision diagnostic tests that addresses unmet clinical needs, announced today corrections to the second paragraph of its press release under the same headline sent out on August 8, 2025. The corrected release follows:

New Novartis ESC data highlights strength of cardiovascular portfolio

PRESS RELEASE Two VictORION studies will highlight Leqvio’s impact on patient quality of life, and as a cholesterol lowering monotherapyLp(a)FRONTIERS APHERESIS study will assess effect of pelacarsen on reducing need for lipoprotein apheresis – a cholesterol removal procedure similar to dialysisPARACHUTE-HF study will highlight the efficacy and safety of Entresto to treat heart failure with reduced ejection fraction due to chronic Chagas diseaseAdditional presentations will assess the safety of new pipeline asset abelacimab in atrial fibrillation Basel, August 18, 2025 – Novartis will present data from 19 abstracts across its cardiovascular portfolio at the 2025 European Society of Cardiology (ESC) Congress in Madrid from August 29 to September 1, 2025. “The latest data we are presenting at ESC will showcase how Novartis is pioneering groundbreaking treatments that can transform cardiovascular outcomes,” said Ruchira Glaser, M.D., Global Head, Cardiovascular, Renal and Metabolic Development Unit, Novartis. “With established treatments Entresto and Leqvio, we continue to explore new ways to improve patient care whilst also investigating broader populations who may benefit. With promising pipeline assets, pelacarsen and abelacimab, we are tackling areas of significant unmet need to address the myriad of factors that cause or worsen heart disease.” Key highlights of data accepted by ESC include: Medicine   Presentation Title   Presentation Details Pelacarsen   Pelacarsen reduces the need for lipoprotein apheresis in patients with elevated lipoprotein(a) and cardiovascular disease: The Phase 3 Lp(a)FRONTIERS APHERESIS trial   Station 12 (Research Gateway) Moderated ePoster August 29, 09:15-10:00 CEST           Pelacarsen   Association of elevated lipoprotein(a) with future major adverse cardiovascular events in recurrent ASCVD patients: analysis of a large US electronic health record database   Station 2 (Research Gateway) Moderated ePoster August 30, 17:15 – 18:00 CEST       Pelacarsen   Economic burden of elevated lipoprotein(a) in secondary prevention of atherosclerotic cardiovascular disease cohort from England   Discovery Pole (North Convention Centre) Poster August 29, 15:15 CEST       Leqvio   VICTORION-Difference study: Inclisiran-based strategy vs standard of care   Madrid (Main Auditorium) Hot Line August 30, 17:00 CEST       Leqvio   VICTORION-Mono China: efficacy and safety of inclisiran as monotherapy in Chinese adults with low or moderate ASCVD risk and elevated LDL-C   Discovery Pole (North Convention Centre) Poster August 29, 10:00 CEST       Abelacimab     Prior anticoagulation experience, bleeding risk, and safety of factor XI inhibition in atrial fibrillation: an analysis of AZALEA-TIMI 71   Science Box 3 (Research Gateway) Poster September 1, 14:30 CEST       Abelacimab   Renal function and factor XI inhibition in atrial fibrillation: a pre-specified analysis of AZALEA-TIMI 71   Science Box 3 (Research Gateway) Poster September 1, 15:00 CEST       Entresto   PARACHUTE-HF: Randomized trial comparing sacubitril/valsartan with enalapril in patients with HFrEF caused by chronic Chagas cardiomyopathy   Madrid (Main Auditorium) Hot Line September 1, 8:15 CEST       About Novartis in Cardiovascular DiseaseAt Novartis, our mission is to ensure no heart is lost too soon. We envision a world where preventable CV deaths are no longer part of our lives. We’re proud of the positive impact we’ve made over the past 40 years and remain dedicated to tackling the most challenging problems in CVD. Through cutting-edge science and technology, we are focusing on areas of high unmet need, including scaling our xRNA platform across multiple risk factors and pioneering breakthroughs for genetically driven CVD risk factors and common heart conditions, including atrial fibrillation. We also work with patients, healthcare professionals, and organizations around the world to improve CV care beyond medicine alone. Together, we can help people with CVD enjoy longer, healthier lives and more time with their loved ones. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. # # # Novartis Media RelationsE-mail: media.relations@novartis.com   Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com 

Simpson Interventions Announces First Patients Treated in Clinical Trial for its Acolyte™ Catheter System

The first patients were treated at Emory University Hospital using the Acolyte Image-Guided Crossing and Re-Entry Catheter System Trial sites are planning to treat a minimum of 103 lesions, at as many as 15 sites The Acolyte Catheter System is intended to provide interventional cardiologists real-time visualization of intravascular morphology […]