Coronary/Structural Heart

Supira Medical Announces FDA Approval for SUPPORT II Pivotal Trial, Advances in Cardiogenic Shock, and Appointment of D. Keith Grossman to Board of Directors

Milestones underscore clinical progress and strengthen commercial foundation LOS GATOS, Calif., April 8, 2026 /PRNewswire/ — Supira Medical, Inc. (Supira), a clinical-stage company focused on transforming the percutaneous ventricular assist device (pVAD) market, today announced FDA approval to initiate the SUPPORT II Pivotal Trial. The trial is designed to support a future PMA submission and […]

ACHIEVE-4, the longest Phase 3 study of Lilly’s Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health

In ACHIEVE-4, Foundayo met the primary objective of non-inferiority vs. insulin glargine with a 16% lower risk of MACE-4 events and a 23% lower risk of MACE-3 events In a pre-planned analysis, the risk of all-cause death was 57% lower for Foundayo vs. insulin glargine, showing the…

Picard Medical / SynCardia Highlights Total Artificial Heart Bridge to Transplant Case at Texas Children’s Hospital

SynCardia Total Artificial Heart supports patient through complex re-transplant journeyTUCSON, Ariz., April 15, 2026 (GLOBE NEWSWIRE) — Picard Medical, Inc. (NYSE American: PMI) (“Picard Medical” or the “Company”), parent company of SynCardia Systems, LLC, maker of the world’s first total artificial heart approved by both the U.S. FDA and Health Canada, today highlighted the successful use of the SynCardia Total Artificial Heart (“STAH”) as a bridge to heart transplantation at Texas Children’s Hospital (“Texas Children’s”), supporting a 21-year-old patient through a complex re-transplant journey. Texas Children’s recently featured the case of Gregory, a now 21-year-old patient who had received his first heart transplant at Texas Children’s in 2017 at the age of 13 following multiple congenital heart defects. In early 2025, Gregory was admitted to Texas Children’s after presenting with chest pain and was diagnosed with rejection of his first transplanted heart. With his original transplant no longer viable and a donor heart unavailable, surgeons implanted the STAH to provide full circulatory support. Gregory was supported on the STAH for approximately two and a half months before a suitable donor heart became available. He subsequently underwent successful heart transplantation and, following an extended recovery, was discharged from the hospital. The STAH is designed to replace the function of both ventricles in patients with end-stage biventricular failure, enabling stabilization, organ recovery, and improved candidacy for transplantation. Its use in complex clinical scenarios, including re-transplantation in young adults with congenital heart disease, demonstrates the flexibility and durability of the therapy in supporting some of the most critically ill patients. Patrick NJ Schnegelsberg, Chief Executive Officer of Picard Medical, commented, “Performing a successful re-transplantation in a young adult with congenital heart disease is among the most complex scenarios in cardiac surgery. In this instance at Texas Children’s, the STAH allowed the clinical team to stabilize the patient and effectively buy time following the diagnosis of rejection until a suitable donor organ became available. Although the support period in this case was relatively short compared with many other cases, the immediate availability of the STAH was essential in enabling a successful outcome. Experiences like this also reinforce why we are developing the Emperor Total Artificial Heart, our next generation fully implantable total artificial heart, designed to remove the external driver and ultimately serve as a potential alternative to heart transplantation for certain patients.” Picard Medical continues to support leading transplant centers across the United States and globally, advancing the use of the STAH to improve outcomes for patients with advanced heart failure. Picard is also advancing development of the Emperor Total Artificial Heart, a fully implantable next-generation device designed to expand access to long-term mechanical circulatory support without the need for external pneumatic drivers. About Texas Children’s Hospital Texas Children’s, a nonprofit health care organization, is committed to creating a healthier future for children and women throughout the global community by leading in patient care, education and research. Consistently ranked as the best children’s hospital in Texas and among the top in the nation, Texas Children’s has garnered widespread recognition for its expertise and breakthroughs in pediatric and women’s health. The system includes the Texas Children’s Duncan NRI; the Feigin Tower for pediatric research; Texas Children’s Pavilion for Women, a comprehensive obstetrics/gynecology facility focusing on high-risk births; Texas Children’s Hospital West Campus, a community hospital in suburban West Houston; Texas Children’s Hospital The Woodlands, the first hospital devoted to children’s care for communities north of Houston; and Texas Children’s Hospital North Austin, the new state-of-the-art facility providing world-class pediatric and maternal care to Austin families. The organization also created Texas Children’s Health Plan, the nation’s first HMO focused on children; Texas Children’s Pediatrics, the largest pediatric primary care network in the country; Texas Children’s Urgent Care clinics that specialize in after-hours care tailored specifically for children; and a global health program that is channeling care to children and women all over the world. Texas Children’s Hospital is affiliated with Baylor College of Medicine. For more information, visit www.texaschildrens.org. About Picard Medical and SynCardia Picard Medical, Inc. is the parent company of SynCardia Systems, LLC (“SynCardia”), the Tucson, Arizona–based leader with the only commercially available total artificial heart technology for patients with end-stage heart failure. SynCardia develops, manufactures, and commercializes the SynCardia Total Artificial Heart (“STAH”), an implantable system that assumes the full functions of a failing or failed human heart. It is the first artificial heart approved by both the FDA and Health Canada, and it remains the only commercially available artificial heart in the United States and Canada. With more than 2,100 implants performed at hospitals across 27 countries, the STAH is the most widely used and extensively studied artificial heart in the world. For additional information about Picard Medical, please visit www.picardmedical.com or review the Company’s filings with the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov. Forward-Looking Statements This press release includes forward-looking statements that involve risks and uncertainties. Forward-looking statements are statements that are not historical facts. Such forward-looking statements are subject to risks and uncertainties, which could cause actual results to differ from the forward-looking statements. The Company expressly disclaims any obligations or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with respect thereto or any change in events, conditions or circumstances on which any statement is based. Additional information about the Company, including risk factors that may affect the Company’s business, financial condition, and results of operations, is contained in the Company’s filings with the SEC, including the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, which are available free of charge on the SEC’s website at http://www.sec.gov and on the Company’s investor relations website at https://picardmedical.com/. Contact: Investors Eric Ribner Managing Director LifeSci Advisors LLC eric@lifesciadvisors.com Picard Medical, Inc./SynCardia Systems, LLC IR@picardmedical.com General/Media Brittany Lanza blanza@syncardia.com

Elucid Announces Commercial Availability of Lesion Inspection Tool for Plaque-IQ™

BOSTON–(BUSINESS WIRE)– #CardiacImaging–Elucid announced today the commercial availability of a new Lesion Inspection Tool for coronary and carotid plaque analysis in its novel Plaque-IQ software suite. The tool provides physicians the ability to interrogate lesion-specific composition and plaque burden across any vessel, which can help the physician better understand the patient risk profile to enhance clinical decision-making. “The Lesion Inspection Tool provides a detailed view of plaque composition at the

New STORM-PE Data Show Computer Assisted Vacuum Thrombectomy with Anticoagulation Resulted in Significantly Better Functional Outcomes at 90 Days Compared to Anticoagulation Alone for Pulmonary Embolism Patients

ALAMEDA, Calif., April 13, 2026 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN) announced 90-day results of the landmark STORM-PE randomized controlled trial (RCT), which found that patients with acute intermediate-high risk pulmonary embolism (PE) who were treated with computer assisted vacuum thrombectomy (CAVT™) plus anticoagulation achieved greater functional improvement, including walking significantly further and […]

Transeptal Mitral Annuloplasty With the AMEND System: 6-Month Results of First in Man Cohort in Circulation: Cardiovascular Interventions

Transeptal Mitral Annuloplasty With the AMEND System: 6-Month Results of First in Man Cohort, by Drs. Melica, Carasso, Butnaru, Gogorishvili, Metreveli, Modine, Kurashvili, Farkash, Meerkin, has been accepted for publication in Circulation: Cardiovascular Interventions. Background: The AMEND implant is a semi-rigid closed D-shaped annuloplasty ring deployed through a transvenous transeptal […]

Bracco Affirms ASNC Position Statement Elevating Cardiac PET with Myocardial Blood Flow as Preferred Standard for Coronary Artery Disease

Guidance validates the comprehensive approach Bracco has advanced for more than three decades NEEDHAM, Mass., April 13, 2026 /PRNewswire/ — Bracco, the market leader in diagnostic imaging and the pioneer in cardiac positron emission tomography (PET) for more than three decades, today…

First Implant of KingstronBio’s ProStyle M® Transcatheter Mitral Valve System Successfully Completed in National Multicenter Confirmatory Study

SHANGHAI, April 9, 2026 /PRNewswire/ — On March 12, 2026, the first implant of the ProStyle M® Transcatheter Mitral Valve System (ProStyle M®) was successfully completed under pure ultrasound guidance as part of its confirmatory clinical study. The device is independently developed by…