The Latest Cardiac and Vascular News
WHITE PLAINS, N.Y., June 5, 2026 /PRNewswire/ — Retia Medical, a cardiovascular intelligence software company, today announced the expansion of its commercial relationship with Medtronic to include distribution of the Argos® Cardiac Output Monitor across Western Europe. The agreement…
SUNNYVALE, Calif., June 05, 2026 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announced receipt of FDA minutes from its Q-Sub Meeting with FDA Center for Biologics Evaluation and Research (CBER) on the CardiAMP Cell Therapy System for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF). The meeting minutes from FDA confirm that the ongoing CardiAMP Heart Failure II Trial may support Premarket Approval (PMA) for market clearance. PMA is the most rigorous type of device marketing application required by the agency. It is used to establish the safety and effectiveness of high-risk medical devices prior to them being approved for public use. FDA had previously indicated that they typically like to see two well designed trials for approval, particularly in large clinical indications such as HFrEF, where there are potentially over one million patients who could benefit from CardiAMP Cell Therapy in the United States. FDA has also previously demonstrated that they consider the CardiAMP Cell Therapy System safe, as this FDA determination is required to enable the Centers for Medicare and Medicaid to reimburse in the CardiAMP HF trials. “Patients with ischemic Heart Failure of reduced Ejection Fraction are in great need for therapeutic options,” said Peter Altman, PhD, BioCardia’s Chief Executive Officer. “FDA recognizes this need and the strengths in our completed CardiAMP HF clinical data to be the first of two trials to support Premarket Approval.” About CardiAMP Cell Therapy Granted FDA Breakthrough designation, CardiAMP Cell Therapy uses a patient’s own bone marrow cells delivered to the heart in a minimally invasive, catheter-based procedure intended to increase capillary density and reduce tissue fibrosis of myocardial tissue to address microvascular dysfunction. Japan Pharmaceutical and Medical Device Agency has indicated that the clinical results from three completed clinical trials for the treatment of ischemic heart failure likely provide sufficient evidence of safety and efficacy to support a successful submission for approval. Clinical development of the CardiAMP Cell Therapy for heart failure is supported by the Maryland Stem Cell Research Fund and is reimbursed by Centers for Medicare and Medicaid Services (CMS). CAUTION – Limited by United States law to investigational use. About BioCardia® BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three cardiac clinical stage product candidates in development. These therapies are enabled by its Helix™ biotherapeutic delivery and Morph® vascular navigation product platforms, and soon the Heart3D™ fusion imaging platform. BioCardia selectively partners on biotherapeutic delivery with peers developing important biologic therapies. For more information visit www.biocardia.com. Upcoming Catalysts in 2026: CardiAMP HF Manuscript PublishedCardiAMP HF Japan PMDA Submission Q4 2026 Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, statements relating to submission for and subsequent market clearance of the CardiAMP Cell Therapy. These forward-looking statements are made as of the date of this press release. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. Factors that could cause or contribute to such differences include, but are not limited to, the Company’s liquidity position and its ability to raise additional funds, as well as the Company’s ability to successfully progress its clinical trials. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 24, 2026, under the caption titled “Risk Factors” and in its subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Media Contact: Miranda Peto, Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact: David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
IRVINE, Calif., June 03, 2026 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the appointment of Maria Jose Arana as Vice President of Quality and Compliance. Maria Jose will lead the company’s quality assurance and compliance strategy, overseeing the implementation of critical quality and compliance systems as JenaValve expands its commercial operations and advances its clinical programs. Her appointment continues the company’s commitment to quality and patient safety during a pivotal period of organizational growth and commercial expansion following the recent FDA approval of the Trilogy THV System for high risk, symptomatic, severe aortic regurgitation (ssAR). Maria Jose brings more than 25 years of executive leadership experience in quality and regulatory affairs across medical devices, diagnostics, and combination product environments. She has a proven track record of building and scaling compliant Quality Management Systems (QMS), advancing regulatory workflows, and leading global inspection readiness programs across organizations. Most recently, Maria Jose served as Senior Director of Quality & Compliance at Johnson & Johnson Electrophysiology, where she led global Quality Systems, Compliance, and Quality Engineering organizations of more than 300 employees across cardiovascular device portfolios spanning predevelopment through commercialization. Prior to J&J, she served as Head of Quality & Compliance at Accriva Diagnostics, leading global QMS and validation teams across multiple markets. She also held quality and regulatory leadership roles at Volcano Corporation, CryoCor, and Medtronic Vascular. Maria Jose holds advanced degrees from Instituto Tecnologico de Monterrey and is certified as a Six Sigma Black Belt and ISO 13485 Lead Auditor. “Maria Jose’s appointment comes at an important moment for JenaValve,” said John Kilcoyne, CEO of JenaValve. “With FDA approval and U.S. commercial launch behind us, we are expanding meaningfully, and the quality and compliance infrastructure we build now will be foundational to our long-term success. Maria Jose brings quality and compliance expertise, cross-functional partnership skills, and the depth of leadership that this stage of growth demands. I look forward to working closely with her as we continue to advance the Trilogy System and expand access to treatment for patients suffering from high risk ssAR.” “I am thrilled to join JenaValve at such a defining moment in the company’s evolution,” said Maria Jose Arana, Vice President of Quality and Compliance at JenaValve. “The clinical evidence supporting the Trilogy System is compelling, and the opportunity to build a world-class quality organization that supports both the commercial launch in the U.S. and the ongoing ARTIST trial is an incredible privilege. I look forward to partnering with the JenaValve team to ensure the highest standards of quality and compliance as we work to bring this life-changing therapy to the broadest group of patients suffering from AR.” About the Trilogy™ THV SystemThe Trilogy THV System is the first and only transcatheter heart valve in the United States indicated for native, symptomatic, severe aortic regurgitation in patients who are judged by a Heart Team to be at high or greater risk for surgical aortic valve replacement. The Trilogy THV System received CE Mark in 2021, and has now been used in more than 1,000 commercial procedures in Europe. The Trilogy System was purpose-built to address the unique anatomical challenges of aortic regurgitation (AR). Unlike conventional TAVR valves that rely on annular calcification for anchoring — which is typically absent in AR patients — the Trilogy System features three proprietary radiopaque locators that attach directly to the native aortic leaflets, enabling secure and stable implantation even in the absence of calcium. The locators also provide commissural alignment for precise valve positioning and ensure a reliable seal to minimize paravalvular regurgitation. The system’s large, open-cell nitinol frame is designed to preserve future coronary access. About JenaValveJenaValve Technology, Inc. is a medical device company focused on the design, development, and commercialization of innovative THV solutions for the treatment of patients suffering from heart valve disease. The Company’s Trilogy THV System is a TAVR system designed to treat patients with symptomatic, severe AR, and symptomatic, severe aortic stenosis (AS) who are at high surgical risk. The Trilogy THV System has regulatory approvals in the United States and Europe for its intended use, and reflects JenaValve’s focus on addressing unmet clinical needs in aortic valve disease, including aortic regurgitation. JenaValve is headquartered in Irvine, California, with additional locations in Leeds, United Kingdom, and Munich, Germany. JenaValve is backed by Bain Capital Life Sciences, Andera Partners, Valiance Life Sciences, Rosetta Capital, Cormorant Asset Management, Legend Capital, NeoMed Management, RMM, VI Partners, Pictet Alternative Advisors SA, Qatar Investment Authority (QIA), Innovatus Capital Partners, and Peijia Medical Limited. Additional information is available at www.jenavalve.com. JenaValve Contact:Daniel Sun dsun@jenavalve.com Investor Contacts:Marissa Bych or Webb CampbellGilmartin Group LLCWebb@Gilmartinir.com
LOS ANGELES, June 03, 2026 (GLOBE NEWSWIRE) — RadNet, Inc. (NASDAQ: RDNT) (“RadNet”), a national leader in providing high-quality, cost-effective, fixed-site outpatient diagnostic imaging services through a network of outpatient imaging centers and a premier developer of radiology digital health solutions, today announced that it seeks to secure an incremental term loan in the aggregate principal amount of $200 million (the “Proposed 2026 Incremental Term Loan”) pursuant to a proposed amendment (the “Proposed Amendment”) to its Third Amended and Restated First Lien Credit and Guaranty Agreement, as amended (the “Existing Credit Agreement” and, the transaction, the “Loan Transaction”).
Investments in intracardiac echocardiography (ICE) technologies highlight Medtronic’s commitment to driving durable growth in the cardiac ablation business through a differentiated portfolio of technologies GALWAY, Ireland, June 3, 2026 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global…
Seasoned medtech entrepreneur brings cardiovascular device, clinical development, financing, and commercialization expertise LONDON, June 3, 2026 /PRNewswire/ — Precision Cardiovascular, a medical technology company developing novel remote monitoring solutions for heart failure…
Financing supports the approval of U.S. Investigational Device Exemption (IDE), coronary clinical advancement, and expansion into below-the-knee peripheral (BTK) applications. SANTA CLARA, Calif., June 2, 2026 /PRNewswire/ — Advanced NanoTherapies, Inc. (ANT), a clinical-stage medtech…
Serial founder and executive with over 30 years of MedTech experience to lead company through U.S. clinical and commercial expansion LA JOLLA, Calif., June 2, 2026 /PRNewswire/ — Rhythm AI, a MedTech company focused on optimizing atrial fibrillation (AF) procedures and developer of the…
Bunkerhill Health’s FDA-cleared ECG-EF algorithm for the detection of reduced ejection fraction becomes the first cleared AI-ECG algorithm available through MyoVista Insights, advancing HeartSciences’ SaaS-based, recurring-revenue marketplace strategySouthlake, TX, June 02, 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 the commercial release of MyoVista Insights™ version 1.3, a major platform update that introduces the MyoVista Insights AI-ECG Algorithm Marketplace. The Marketplace enables third-party algorithm results to be integrated into the MyoVista Insights platform, beginning with an FDA-cleared AI-ECG model from Bunkerhill Health. The Bunkerhill ECG-EF model enables clinicians to detect reduced left ventricular ejection fraction (LVEF ≤40%) from a routine 12-lead ECG. The launch marks the first time a cleared AI-ECG algorithm is available through MyoVista Insights, making the ECG-EF algorithm accessible to healthcare facilities of every size, from large integrated health systems to community hospitals, critical access hospitals, and primary care practices across the United States. It also establishes the platform as a commercial pathway for AI-ECG developers seeking to reach clinical users through a recurring, SaaS-based revenue model, without the cost or complexity, of building their own end-to-end workflow and distribution infrastructure. HeartSciences is in active discussions to add further third-party owned and cleared algorithms and expects the marketplace to expand over the coming quarters. Andrew Simpson, Chief Executive Officer of HeartSciences, said, “The launch of our AI-ECG marketplace is a defining milestone for HeartSciences. We are now delivering a cleared AI-ECG algorithm into clinical workflows through MyoVista Insights, with a recurring, SaaS-based revenue model that we believe can create meaningful and scalable value for the Company. Bunkerhill’s ECG-EF algorithm is the first of what we expect to be many. We are in active discussions with additional algorithm developers who recognize that delivering algorithms into clinical practice, not simply developing them, is the critical step, and we believe MyoVista Insights is uniquely positioned to be that delivery platform for institutions of every size.” Detection of reduced LVEF from a routine ECG supports earlier identification and is expected to result in more effective referral of patients at risk of heart failure. Assessments performed with assistive AI-ECG algorithms are eligible for Medicare reimbursement under the Hospital Outpatient Prospective Payment System, assigned to Ambulatory Payment Classification (APC) 5734 at a national payment rate of approximately $136 per assessment for 2026. With AI-ECG forecast to become a multi-billion-dollar market, HeartSciences believes an established reimbursement pathway, combined with its recurring SaaS-based revenue model, positions the Company to capture meaningful and scalable revenue as adoption grows and additional algorithms are added to the platform. Nishith Khandwala, Co-founder and Chief Executive Officer of Bunkerhill Health, added, “We share HeartSciences’ commitment to making advanced cardiac AI more accessible in everyday clinical practice. This collaboration gives more health systems a pathway to adopt our FDA-cleared ECG-EF algorithm and to use routine ECG data to support earlier evaluation and more informed clinical decisions for patients at risk of heart failure.” MyoVista Insights is a cloud-native, next-generation ECG management system designed to be device-agnostic that delivers workflow efficiency and third-party, FDA-cleared AI results directly into clinical practice. Because it is cloud-based, cost-effective, and independent of any single manufacturer’s hardware, the platform gives institutions of every size a unified environment for deploying cleared AI-ECG algorithms within routine clinical workflows. MyoVista Insights holds Epic Toolbox designation for the ECG Management System category and supports integration with electronic health records through HL7v2 order and results workflows, single sign-on (SSO), and SMART on FHIR. 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 Bunkerhill Health Bunkerhill Health delivers generative AI for clinical reasoning and action. Its flagship platform, Carebricks, analyzes structured and unstructured patient data to understand each patient’s full history, apply AI-powered reasoning across all available context, and automate next steps. Carebricks helps health systems improve outcomes, increase efficiency, and close care gaps without adding to clinician workload. For more information, please visit https://www.bunkerhillhealth.com/. 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
– Tissue Dynamics identified a previously unrecognized metabolic mechanism driving cardiac fibrosis using a human cardiac organoid model, revealing disease biology that is not accessible through conventional animal models. – In inflammatory human cardiac organoids, the combination of…
