MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments and therapies for atrial fibrillation (Afib), left atrial appendage (LAA) management and post-operative pain management, today announced first quarter 2026 financial results. “Our first quarter results reflect the durability of AtriCure’s growth model, fueled by disciplined execution and increased adoption of our innovative products,” said Michael Carrel, President and Chief Executive Officer
Author: Ken Dropiewski
HeartSciences Signs First SaaS Revenues Agreement following full launch of MyoVista Insights™
Agreement with St. Vincent Health marks HeartSciences’ transition from early adopter installations to commercial SaaS deployments following the full launch of MyoVista Insights at the American College of Cardiology Annual Scientific SessionSouthlake, TX, May 05, 2026 (GLOBE NEWSWIRE) — HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company focused on advancing electrocardiography (“ECG” or “EKG”) through the integration of artificial intelligence (“AI”), today announced that it has signed a commercial agreement with St. Vincent Health, a Critical Access Hospital serving Lake County, Colorado, to deploy the MyoVista Insights™ platform. The agreement marks an important commercial milestone for HeartSciences, representing the Company’s first mainstream revenue-generating deployment of MyoVista Insights, building on previously announced reference and early adopter installations. MyoVista Insights is offered under a SaaS-based recurring revenue model, and HeartSciences is in active discussions with additional healthcare organizations and expects further commercial agreements over the coming quarters. MyoVista Insights is a cloud-native, SaaS-based ECG management platform purpose-built to improve workflow efficiency, provide enterprise-grade EHR interoperability, and enable the deployment of cleared AI-ECG algorithms directly into routine clinical workflows. It is device-agnostic and designed to scale across healthcare facilities of all sizes. Andrew Simpson, Chief Executive Officer of HeartSciences, said, “This agreement represents an important commercial milestone for HeartSciences as we transition from early adopter installations to revenue-generating deployments of MyoVista Insights. Following our full launch at ACC, we are seeing strong market interest in a scalable, device-agnostic ECG management platform designed to bring AI-enabled cardiac insights into everyday clinical workflows. We believe this agreement is the first of multiple commercial opportunities across healthcare organizations of varying sizes.” Justin “Bubba” Bartlett, Chief Executive Officer of St. Vincent Health, added, “At St. Vincent Health, we are focused on bringing modern, high-quality care to our community. MyoVista Insights gives our clinicians a cost-effective, SaaS ECG platform that is easy to deploy, integrates the latest AI directly into existing workflows, and supports our mission to elevate cardiac care for the patients we serve.” For more information about MyoVista Insights™, please visit www.heartsciences.com or follow the Company on X (@HeartSciences). Healthcare providers interested in opportunities may contact info@heartsciences.com. About HeartSciences HeartSciences is a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”). The Company’s MyoVista Insights platform is a device-agnostic, next-generation ECG management system designed to improve clinical efficiency and decision-making. Its MyoVista wavECG device is designed to deliver conventional ECG functionality while supporting on-device AI-enabled solutions. For more information, please visit: https://www.heartsciences.com. X: @HeartSciences About St. Vincent Health St. Vincent Health, located in Leadville, Colorado, is an independent community hospital that has served Lake County since 1879. Operated by the St. Vincent General Hospital District, the hospital provides 24/7 emergency, primary care, surgical, and rehabilitation services to its community. For more information, please visit www.stvincent.health. Safe Harbor Statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. All statements, other than statements of historical facts, included herein are “forward-looking statements” including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ Annual Report on Form 10-K for the fiscal year ended April 30, 2025, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 24, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended July 31, 2025 filed with the SEC on September 11, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended October 31, 2025 filed with the SEC on December 15, 2025, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2026 filed with the SEC on March 16, 2026, and in HeartSciences’ other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements. Investor Relations: Integrous CommunicationsMark Komonoski, PartnerPhone: 877 255 8483Email: mkomonoski@integcom.us Media Contact: HeartSciencesGene GephartPhone: +1 682 244 2578 Ext. 2024Email: info@heartsciences.com
Microbot Medical®’s LIBERTY® Endovascular Robotic System is Now Adopted by Multiple Accounts Across Key Territories Including Two ACCESS-PVI Pivotal Clinical Trial Sites
Microbot Medical®’s LIBERTY® System is Now Adopted by Multiple Accounts Across Key Territories Including Two ACCESS-PVI Pivotal Clinical Trial Sites
Anteris Technologies Announces First U.S. Patients Treated in Global Pivotal PARADIGM Trial
MINNEAPOLIS and BRISBANE, Australia, May 05, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR), a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function, today announced that the first patients in the United States have been enrolled and successfully treated in the DurAVR® Transcatheter Heart Valve (“THV”) global pivotal trial for patients with severe calcific aortic stenosis (the “PARADIGM Trial”). The procedures were performed by Azeem Latib, M.D. at Montefiore Medical Center, New York, United States. “Performing the first U.S. cases in the global PARADIGM Trial is a significant achievement for trial investigators, and our early procedural experience with the DurAVR® THV System has been highly encouraging,” said Dr. Latib, Principal Investigator and Director of Interventional Cardiology and Director of Structural Heart Interventions at Montefiore. “PARADIGM is specifically designed to answer clinically meaningful questions and go beyond the usual safety metrics and hemodynamics by also looking at the impact of flow patterns on left ventricular recovery. Initiating enrollment represents a critical step toward generating the evidence needed to inform future patient care.” “Following CMS approval, the Anteris team and our physician partners worked closely together to achieve first patient enrollments within the week. This marks a major milestone for the PARADIGM Trial as our U.S. study sites come on line and expand recruitment capability,” said Wayne Paterson, Vice Chairman and Chief Executive Officer of Anteris. About the PARADIGM Trial The PARADIGM Trial is a prospective randomized controlled trial which will evaluate the safety and effectiveness of the DurAVR® THV compared to commercially available transcatheter aortic valve replacements (TAVRs). This head-to-head study will enroll approximately 1000 patients in the ‘All Comers Randomized Cohort’ with 1:1 randomization of patients who will receive either the DurAVR® THV or TAVR using commercially available and approved THVs. The PARADIGM Trial will assess non-inferiority on a primary composite endpoint of all-cause mortality, all stroke and cardiovascular hospitalization at one year post procedure. For further information, please refer to ClinicalTrials.gov NCT07194265. About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global structural heart company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements, including the quotes contained herein. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Global Investor RelationsInvestor Relations (US)investors@anteristech.commchatterjee@bplifescience.comDebbie Ormsby Malini Chatterjee, Ph.D.Anteris Technologies Global Corp.Blueprint Life Science Group+61 1300 550 310 | +61 7 3152 3200+1 917 330 4269 Website www.anteristech.comX@AnterisTechLinkedInhttps://www.linkedin.com/company/anteristech
CVRx Announces First Patient Enrollment in BENEFIT-HF, a Landmark Heart Failure Trial Evaluating Barostim in Significantly Expanded Population
MINNEAPOLIS, May 04, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX), a medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced the enrollment of the first patient in the landmark BENEFIT-HF trial at North Central Heart – a division of the Avera Heart Hospital, in Sioux Falls, S.D. by Dr. Orvar Jonsson. BENEFIT-HF is expected to be one of the largest therapeutic cardiac device trials ever performed in heart failure, enrolling 2,500 patients at approximately 150 centers in the United States and Germany. The prospective, randomized, controlled, multicenter trial is supported by CMS Category B IDE coverage and designed to evaluate all-cause mortality and heart failure decompensation events in a significantly expanded heart failure population. “We are honored to enroll the first patient in the BENEFIT-HF trial,” said Dr. Orvar Jonsson, North Central Heart – a division of the Avera Heart Hospital. “This study will evaluate Barostim therapy in a broader population of patients who remain symptomatic despite optimized guideline-directed medical therapy, generating important data that will further define Barostim’s position in the heart failure continuum.” “Achievement of this early milestone reflects tremendous excitement in the healthcare community regarding this landmark trial, and strong execution by the CVRx team in partnership with BENEFIT-HF investigators,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “We are proud to collaborate with leading physicians in development of such meaningful clinical evidence, and excited to further characterize the patient benefits of Barostim therapy that we believe will drive long-term adoption.” The BENEFIT-HF trial is expected to continue through 2032. If successful, the Trial could expand the indicated patient population for Barostim by approximately three times, significantly broadening access to the therapy. About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking StatementsThis press release contains forward-looking statements, including statements regarding the expected timing, enrollment, scope, and outcomes of the BENEFIT-HF clinical trial, potential expansion of the Barostim indication, and anticipated benefits of Barostim therapy. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our expectations regarding enrollment; the resulting impact on our addressable market; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product, including those resulting from the BENEFIT-HF clinical trial; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com
Cytokinetics to Announce Topline Results from ACACIA-HCM, the Pivotal Phase 3 Clinical Trial of Aficamten in Patients with Non-Obstructive Hypertrophic Cardiomyopathy, on May 5, 2026
Company to Host Conference Call and Webcast Tuesday May 5 at 8:00 AM Eastern Time SOUTH SAN FRANCISCO, Calif., May 04, 2026 (GLOBE NEWSWIRE) — Cytokinetics, Incorporated (Nasdaq: CYTK) today announced it will report topline results from ACACIA-HCM (Assessment Comparing Aficamten to Placebo on Cardiac Endpoints In Adults with Non-Obstructive HCM) on Tuesday, May 5, 2026. Following the announcement, Cytokinetics will host a conference call at 8:00 AM Eastern Time to discuss the results. The conference call will be simultaneously webcast and can be accessed from the Investors & Media section of Cytokinetics’ website at https://ir.cytokinetics.com or the following link: ACACIA-HCM Topline Results. An archived replay of the webcast will be available via Cytokinetics’ website for six months. About Cytokinetics Cytokinetics is a specialty cardiovascular biopharmaceutical company, building on its over 25 years of pioneering scientific innovations in muscle biology, and advancing a pipeline of potential new medicines for patients suffering from diseases of cardiac muscle dysfunction. Cytokinetics’ MYQORZO® (aficamten) is a cardiac myosin inhibitor approved in the U.S., Europe and China for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). Cytokinetics is also developing omecamtiv mecarbil, an investigational cardiac myosin activator for the potential treatment of patients with heart failure with severely reduced ejection fraction and ulacamten, an investigational cardiac myosin inhibitor for the potential treatment of heart failure with preserved ejection fraction, while continuing pre-clinical research and development in muscle biology. For additional information about Cytokinetics, visit www.cytokinetics.com and follow us on X, LinkedIn, Facebook and YouTube. Disclaimer Omecamtiv mecarbil and ulacamten are investigational medicines. They have not been approved nor determined to be safe or efficacious for any disease state or any indication by FDA or any other regulatory agency. Forward-Looking Statements This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the “Act”). Cytokinetics disclaims any intent or obligation to update these forward-looking statements and claims the protection of the Act’s Safe Harbor for forward-looking statements. Examples of such statements include, but are not limited to, statements relating to Cytokinetics’ and its partners’ research and development activities of Cytokinetics’ product candidates. Such statements are based on management’s current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to the risks related to Cytokinetics’ business outlines in Cytokinetics’ filings with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and Cytokinetics’ actual results of operations, financial condition and liquidity, and the development of the industry in which it operates, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that Cytokinetics makes in this press release speak only as of the date of this press release. Cytokinetics assumes no obligation to update its forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release. CYTOKINETICS® and the CYTOKINETICS C-shaped logo are registered trademarks of Cytokinetics in the U.S. and certain other countries. MYQORZO® is a registered trademark of Cytokinetics in the U.S. and the European Union. Contact:Cytokinetics Diane WeiserSenior Vice President, Corporate Affairs(415) 290-7757
TruLeaf Medical, a fully-owned subsidiary of Allmed Solutions successfully Completed the Second Stage of valve implantation in two Additional Patients
In a follow up of up to nine months, TruLeaf Proprietary RoseDoc Docking System Demonstrates Exceptional Clinical Safety and Efficacy for transcatheter tricuspid valve replacement. OR YEHUDA, Israel, May 4, 2026 /PRNewswire/ — TruLeaf Medical, Ltd, a fully-owned subsidiary of Allmed…
Pulse Biosciences Reports Business Updates and First Quarter 2026 Financial Results
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), developer of novel nPulse™ technology using proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced business updates and financial results for the first quarter ended March 31, 2026. Recent Business Highlights Endocardial Catheter AF Ablation Announced strategic prioritization of the nPulse Cardiac Catheter System following landmark clinical data, presented at AF Symposium, demonst
InspireMD Announces FDA Approval of Investigational Device Exemption Application for CGUARDIANS III Pivotal Study of the SwitchGuard Neuro Protection System
MIAMI, May 01, 2026 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced that the U.S. Food and Drug Administration (“FDA”) has approved the company’s Investigational Device Exemption (“IDE”) Application to initiate the CGUARDIANS III pivotal study of its SwitchGuard neuro protection system (“NPS”), including next generation enhancements from our prior IDE approval for use with its CGuard Prime 80 cm stent platform, in transcarotid artery revascularization (“TCAR”) procedures.
Retia Medical Presents First Public Results for Non-Invasive Cardiac Output Algorithm
WHITE PLAINS, N.Y., May 1, 2026 /PRNewswire/ — Retia Medical today announced the first public presentation of results from its non-invasive cardiac output algorithm, which estimates cardiac output using signals from sensors already placed on patients as standard of care: a pulse oximeter…
