The Latest Cardiac and Vascular News
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…
ATLANTA, April 8, 2026 /PRNewswire/ — MiRus today announced successful enrollment and treatment of the first patients in the STAR Trial, a prospective, multicenter, randomized controlled trial studying the Siegel™ 8-Fr aortic transcatheter heart valve (THV). The first procedures were…
Rigorous training and certification gives clinicians a validated pathway to AI-enabled cardiac POCUS proficiencyROCKVILLE, Md. and BORDEAUX, France, April 07, 2026 (GLOBE NEWSWIRE) — HeartFocus, the AI-enabled cardiac imaging software developed by data-driven medtech company DESKi, today announced a partnership with Inteleos® through its Point-of-Care Ultrasound (POCUS) Certification Academy™. Together, they are launching the HeartFocus POCUS Certification, a fast, accessible, and comprehensive training pathway designed to provide healthcare professionals with a structured pathway to AI proficiency in cardiac ultrasound and to help them confidently perform high-quality heart scans at the point of care with HeartFocus. As cardiovascular disease continues to rise, AI-powered cardiac POCUS is emerging as a cost-effective way to expand access to earlier detection. While AI adoption in healthcare has accelerated, training and trust have lagged — this collaboration closes the gap by operationalizing competency and validation for frontline users. A recent HeartFocus study revealed that 69% of Americans are comfortable with AI-enabled cardiac care, signaling that clinicians and patients are ready for AI; what has been missing is a validated, competency-based route to use it responsibly. The HeartFocus POCUS Certification was developed with this in mind, combining DESKi’s HeartFocus AI-enabled cardiac imaging solution with the POCUS Certification Academy’s rigorous assessment standards to provide a structured course with guided hands-on scanning and expert image review to validate cardiac POCUS proficiency across diverse care settings. Key elements include: Structured training and assessment: covering core cardiac ultrasound fundamentals and the use of HeartFocus, followed by a final knowledge assessment within a competency-based framework.Practical skills validation: remote evaluation of images created using HeartFocus, by experts to assess diagnostic quality and confirm consistent performance.Recognized certification: a personal credential demonstrating verified competency in cardiac POCUS using HeartFocus, enabling clinicians and institutions to demonstrate responsible AI use. “POCUS is rapidly becoming a core competency for clinicians everywhere, but education and objective skills validation must keep pace with technology,” said Jasmine Rockett, Inteleos® POCUS Certification Academy Director. “While AI adoption in healthcare has accelerated, training and trust have lagged — this collaboration closes that gap by providing a validated, competency-based route to use AI responsibly. Through this partnership with DESKi and the launch of the HeartFocus POCUS Certification, we are offering a scalable, competency-based pathway that helps clinicians gain confidence in cardiac ultrasound assisted by AI while helping health systems standardize quality and reduce variability in care.” Bertrand Moal, PhD, MD, CEO of DESKi said, “HeartFocus was created to make world-class echocardiography accessible to any trained healthcare professional at the bedside. The response since our launch has been overwhelmingly positive, but clinicians have communicated that confidence is a barrier. This certification closes that gap, giving healthcare professionals a practical way to build skills and bring high-quality cardiac imaging into everyday care.” The certification is available for healthcare institutions or medical professionals globally, and helping organizations operationalize trusted, competency-based AI use in cardiac POCUS. To learn more about The HeartFocus POCUS Certification, visit www.pocus.org/heartfocus About Inteleos Inteleos™ is a non-profit organization dedicated to ensuring equitable access to quality healthcare globally. It oversees the American Registry for Diagnostic Medical Sonography® (ARDMS®), the Alliance for Physician Certification & Advancement™ (APCA™), and the Point-of-Care Ultrasound Certification Academy™ (PCA), collectively representing 150,000+ certified medical professionals worldwide. About HeartFocusHeartFocus is an FDA-cleared, AI-powered cardiac ultrasound application designed to expand access to diagnostic-quality heart imaging at the point of care. Using real-time AI guidance and automatic image quality validation, it enables healthcare professionals – including physicians, nurses, PAs, and NPs – to capture clinical-grade cardiac ultrasound scans after just hours of training. Built on proprietary algorithms trained on millions of data points and validated through clinical studies, HeartFocus supports standard transthoracic views and integrates with existing ultrasound and DICOM/PACS workflows. Developed by DESKi, HeartFocus is driven by the belief No heart can wait™, helping clinicians identify cardiac conditions earlier across primary care, emergency, and frontline settings. Learn more at www.heartfocus.ai HeartFocus by DESKi Inquiries: Pernille Bruun-Jensen, Chief Growth Officermediarelations@deski.ai Inteleos Inquiries: Lisa Jordan, Director of Brand Strategy and Communications Lisa.jordan@inteleos.org
MINNEAPOLIS, April 06, 2026 (GLOBE NEWSWIRE) — Egg Medical announces the launch of EggNest™ Complete Flex, a groundbreaking advancement in radiation protection that enables clinicians to safely work apron-free or with ultralight lead aprons—without the need for construction, structural modifications or procedural downtime. The first live case with Complete Flex will be performed by Dr. Jasvindar Singh at Barnes-Jewish Hospital on Wednesday, April 8th at 9:35 a.m. CST as a part of the ARCH 2026 meeting. “We are excited to be the first to use this novel technology in a live case and believe it is important to adopt solutions that protect everyone,” said Dr. Jasvindar Singh, Section Chief of Interventional & Structural Cardiology at Barnes-Jewish Hospital and Chairman of ARCH Consortium. “ARCH continues to innovate and remains on the cutting-edge of new technology,” said Dr. George Chrysant, Course Director of ARCH and Chief Medical Officer of Integris Cardiovascular Physicians. “I’ve used the EggNest Complete for a year and am convinced that Enhanced Radiation Protection Devices (ERPDs) should no longer be an option when the welfare of the team is at stake.” Unlike other ceiling-mounted radiation shielding systems that require extensive construction and room downtime, EggNest Complete Flex sets a new standard in radiation protection: Construction-Free: No structural changes, permitting or installation delays.Zero Downtime: Labs remain operational during installation, preserving millions in potential revenue.Cost-Saving: Eliminates renovation costs associated with other built-in shielding solutions.Clinician-Friendly: Enables apron-free workflows or the use of ultralight lead, reducing orthopedic strain and long-term injury risk. “Healthcare systems have been forced to choose between clinician safety, operational disruption, and significant capital investment,” said Gavin Philipps, Chief Commercial Officer at Egg Medical. “Now hospitals can protect their team without shutting down rooms for multiple days or spending hundreds of thousands on construction.” Health systems are under increasing pressure to improve staff retention, reduce occupational hazards and maintain procedural throughput. A recent publication in JSCAI endorsed by multiple medical societies called for broader adoption of ERPDs to address these issues¹. Adoption is accelerating; the solution is currently installed in fifteen labs nationwide, with an additional eighty labs expected to be deployed by the end of Q2. Salavitabar A, Vora A, Altschul D …ALARA+: Summit on Radiation and Orthopedic Risks in Fluoroscopic Laboratories. Journal of the Society for Cardiovascular Angiography & Interventions, 2026; 0 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/14f028e0-82c4-433b-a70a-84b9ad7c33c6 CONTACT: Susan Storm, Marketing Manager, sstorm@eggmedical.com
ST. LOUIS, April 06, 2026 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received U.S. Food and Drug Administration 510(k) clearance for the Synchrony™ system. Synchrony is designed to digitize and modernize the interventional cath lab. Synchrony’s slim and stunning 55” 4K ultra-high-definition display consolidates the viewing and control of all disparate systems in the lab, offering an enhanced procedure experience with custom layouts, streamlined workflows, an intuitive user interface, and a decluttered environment. Synchrony digitizes the video streams with full fidelity and ultra-low latency, offering crystal-clear visualization. Its architecture allows obsolescence protection for labs as new technologies are introduced in the future. Synchrony is made available with SynX™, a cloud-based HIPAA and GDPR-compliant app that allows for secure remote connectivity, collaboration, recording, and monitoring of the cath lab. “We have long recognized that seamless remote connectivity and collaboration for our EP labs could be very beneficial,” said Dr. Mauricio Arruda, Professor of Medicine at Case Western Reserve University School of Medicine and Director of Electrophysiology at University Hospitals Harrington Heart & Vascular Institute. “We are particularly interested in being early pioneers of Synchrony and SynX, and look forward to demonstrating that intraoperative collaboration enhances our ability to provide the best patient care and train the next generation of physicians.” “We are excited by this technology and the opportunity to be among the first to modernize our catheter labs with Synchrony and SynX when the Richard M. Schulze Surgical and Critical Care Center at Abbott Northwestern Hospital opens in late August,” said Daniel Melby, MD, Medical Director of Electrophysiology Labs at Allina Health Minneapolis Heart Institute. “Our cardiology labs have become increasingly busy and complex environments, accentuating the value of technology that enhances procedure workflow, improves lab efficiency and encourages collaboration.” “In my role managing the technology across our electrophysiology labs and advising labs across the country, I have significant experience with various interventional lab display offerings,” said Matthew Dare, CEPS, Research and Technology Coordinator, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center in Austin, Texas. “The underlying hardware and software architecture of Synchrony and SynX is far beyond what anyone else has developed. It promises a better intraoperative experience for physicians and nurses, improved equipment reliability and maintenance, and attractive tools for managing a cardiovascular program with remote monitoring, collaboration and recordings.” Stereotaxis is reiterating its guidance of over $3 Million in revenue this year from Synchrony systems placed independent of robotic systems. Synchrony and SynX have been engineered to be foundational platforms for future innovations. The advanced architecture enables future applications and the leveraging of artificial intelligence for enhanced clinical insights, automation, and safety. “Synchrony and SynX are central to our digital surgery efforts to modernize the interventional lab with enhanced workflow, remote connectivity, and smart AI capabilities,” said David Fischel Stereotaxis Chairman and CEO. “The technology improves the robotic cockpit, and will be critical in supporting robotic efforts for remote long-distance procedures and automated catheter navigation. The opportunity is much broader than robotic labs as we believe all cath labs stand to benefit from improved workflow, connectivity, and collaboration.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com. This press release includes statements that may constitute “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934, including statements regarding the completion of the Company’s offering and the anticipated use of proceeds therefrom, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the SEC. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this press release. There can be no assurance that the Company will recognize revenue related to customer purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com
MAPLE GROVE, Minn.–(BUSINESS WIRE)–VDYNE, Inc. (“VDYNE” or “the Company”), a privately held medical device company developing next generation transcatheter valve replacement technologies, today announced that the U.S. Food & Drug Administration (FDA) has approved an investigational device exemption (IDE) for the company’s pivotal clinical trial evaluating its Transcatheter Tricuspid Valve […]
Expands OEM Platform and Strengthens Leadership in Nuclear Medicine ImagingPITTSBURGH, April 02, 2026 (GLOBE NEWSWIRE) — Catalyst MedTech, a national leader in nuclear medicine and molecular imaging solutions, today announced the acquisition of X3D ApS (“X3D”), the OEM behind widely deployed gamma camera and SPECT systems used in nuclear cardiology and general nuclear medicine. The acquisition builds on Catalyst MedTech’s Digirad portfolio of systems—Ergo, Cardius2 XPO, Cardius3 XPO, and X-ACT+. X3D, formerly DDD-Diagnostic, is a globally recognized engineering and manufacturing partner under private label to leading medical equipment companies, with approximately 5,000 systems installed worldwide. Known for precision engineering, Danish design, and system architecture, X3D has established itself as a trusted force in nuclear medicine and molecular imaging. X3D’s flagship cardiac imaging system, CorCam, is recognized for its diagnostic accuracy, operational efficiency, and compact design. Catalyst MedTech’s acquisition also introduces QuantumCam, a general-purpose gamma camera designed to offer a flexible, space-efficient, and cost-effective solution for hospitals and imaging centers seeking to modernize or expand nuclear medicine capabilities. The combination of Catalyst MedTech’s Digirad portfolio and X3D’s CorCam and QuantumCam creates one of the most comprehensive, versatile offerings in nuclear cardiology and general nuclear medicine. The expanded platform enables Catalyst MedTech to support a broader range of clinical settings while driving innovation across cardiac imaging systems, software, and clinical applications. “This acquisition marks a pivotal step in our strategy to expand access while taking greater ownership of the technologies that power nuclear medicine,” said Martin Shirley, Catalyst MedTech’s President and CEO. “By combining the proven Digirad platform with X3D’s engineering capabilities and global OEM heritage, we are uniquely positioned to accelerate technology, strengthen our market leadership, and ensure long-term support and continuity for thousands of systems already in the field.” Manufacturing of CorCam will transition to the United States, enhancing domestic production capacity and supply chain resilience. X3D’s Denmark-based engineering team will remain in place, continuing to manufacture QuantumCam systems and serving as a key hub for innovation and system development. “We’re proud that our entire organization in Denmark will continue as an integral part of the new Catalyst MedTech structure,” said Admin Ajkunic, X3D’s CEO. “This ensures continuity for our customers and partners, while reinforcing Denmark’s role as a center for innovation and advanced engineering.” About Catalyst MedTech Catalyst MedTech is a national leader in nuclear medicine and molecular imaging, delivering equipment, service, and clinical solutions to healthcare providers across the United States. Our purpose is to provide access to advanced diagnostic imaging so that patients get the care and treatment they need. As both an OEM innovator and ISO-certified service provider, Catalyst offers a comprehensive, multi-vendor approach that enables healthcare organizations to overcome barriers and expand access to advanced diagnostic imaging. The company supports cardiology, neurology, and oncology through advanced imaging technologies, including SPECT, PET, PET/CT, and optimized Brain PET. With one of the largest multi-vendor service networks in the country and a nationwide team of clinical and technical experts, Catalyst ensures imaging programs operate efficiently, reliably, and at scale. See What’s Possible.www.catalystmedtech.com Media Contact: Kate KinsellDirector of MarketingCatalyst MedTechkkinsell@catalystmedtech.com
IRVINE, Calif., April 01, 2026 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the successful first cases and official U.S. commercial launch of the Trilogy THV System, following the U.S. Food and Drug Administration’s (FDA) recent premarket approval (PMA) for the treatment of patients with symptomatic, severe aortic regurgitation (ssAR) who are at high or greater risk for surgical aortic valve replacement (SAVR). The first commercial U.S. procedures were performed simultaneously at NewYork-Presbyterian/Columbia University Irving Medical Center by Dr. Torsten Vahl, at Cedars-Sinai Medical Center by Dr. Raj Makkar and at Piedmont Heart Institute by Dr. Vinod Thourani. The Trilogy THV System is the first and only transcatheter device in the United States with a dedicated indication for high-risk aortic regurgitation (AR) – a historically underserved and underdiagnosed patient population that, until now, had no approved transcatheter treatment option. With its official launch, JenaValve begins a new era in the treatment of AR in America, bringing a minimally invasive, purpose-built solution to the patients who need it most. “It is an honor to have been on this journey with Trilogy from the very first implants of the ALIGN-AR trial to FDA approval and the very first commercial implants” said Dr. Torsten Vahl, director of translational research and interventional cardiologist at NewYork-Presbyterian/Columbia University Irving Medical Center and national PI of the ALIGN-AR trial. “This is a significant achievement for the field and more importantly, for the many thousands of high-risk AR patients that finally have TAVR available as an option to them.” “These first cases are a defining moment for the many Americans who have been suffering from severe aortic regurgitation,” said Raj Makkar, MD, Cedars-Sinai Medical Center, and highest enroller in the ALIGN-AR trial. “I have seen firsthand how many patients need a dedicated treatment option like Trilogy. With this groundbreaking FDA approval and commercial launch, I believe we will soon gain a clearer understanding of how many patients can truly benefit from this important therapy.” “We finally have the option of TAVR for AR patients at high-risk of surgery.,” said Dr. Vinod H. Thourani, Chairman of Cardiovascular Surgery at Piedmont Heart Institute and national PI of the ALIGN-AR trial. “I am excited for what this means for the future of AR treatment because this now opens the door to whether or not we expand this treatment beyond high-risk patients. The randomized ARTIST trial which we are enrolling now will give us the critical answers to that question.” “The commercial launch of Trilogy in the United States is the beginning of a transformation in how we identify, diagnose, and treat aortic regurgitation,” said Peter Spadaro, Chief Commercial Officer of JenaValve. “We have assembled a world-class commercial organization to introduce the Trilogy valve to hospitals throughout the country to ensure patients have access to this therapy. The unmet need is enormous, and we are already experiencing strong demand. We are committed to reaching every patient who can benefit from the Trilogy System, while prioritizing patient outcomes and safety as we expand access to this game changing technology.” 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 1,200 commercial procedures in Europe. The Trilogy System was purpose-built to address the unique anatomical challenges of aortic regurgitation. 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. Dr. Vahl discloses that he previously served as a paid consultant to JenaValve, and reports institutional funding to Columbia University from JenaValve. 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 bears the CE Mark for the treatment of AR and AS and is FDA approved for the treatment of AR. 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
NEW YORK, March 31, 2026 /PRNewswire/ — Acorai is pleased to announce the enrolment of its first patient in the 1000-patient HOSP-HF study (Hemodynamic Observational Study in Patients with Heart Failure using a Non-Invasive Multi-Modal Sensing Device). This multi-site observational study…
Mehran begins a one-year term leading premiere global cardiovascular WASHINGTON, March 30, 2026 /PRNewswire/ — Roxana Mehran, MD, FACC, today assumed the role of president of the American College of Cardiology. Mehran will serve a one-year term at the helm of the almost 60,000-member…
