Coronary/Structural Heart

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…

HeartFocus and Inteleos Launch First AI Cardiac POCUS Certification

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

Egg Medical Launches EggNest™ Complete Flex: Apron-Free Protection Without Construction, Downtime or Disruption

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

Stereotaxis Announces FDA Clearance and Launch of Synchrony System

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

VDYNE Receives FDA Approval to Initiate the TRIVITA1 IDE Pivotal Trial of Transcatheter Tricuspid Valve Replacement System

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 […]

Catalyst MedTech Announces Acquisition of X3D

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