Author: Ken Dropiewski

First Patient Enrolled in Penumbra’s FORWARD Study Evaluating Mechanical Thrombectomy and Computer Assisted Vacuum Thrombectomy for Distal Acute Ischemic Stroke

ALAMEDA, Calif., July 7, 2026 /PRNewswire/ — Penumbra, Inc. (NYSE: PEN), the world’s leading thrombectomy company, announced the initiation of its FORWARD study, an international, real world prospective, multi-center study. The study will collect safety and efficacy data on mechanical…

Cleerly to Debut Customizable Full Text Reports and Present New AI-QCT Research at SCCT2026

DENVER–(BUSINESS WIRE)– #AI–Cleerly, a leader in advanced cardiovascular imaging analysis, will be attending the 21st Annual Scientific Meeting of the Society of Cardiovascular Computed Tomography (SCCT2026). The conference will take place July 9–12, 2026, at the Gaylord Pacific Resort in Chula Vista, California. SCCT2026 brings together clinicians and researchers from around the world to advance the science and practice of cardiovascular computed tomography. Cleerly will debut new customization c

Xeltis makes first commercial implant of aXess™, its vascular access device for hemodialysis

Marks start of European commercial rollout of aXess™, bringing it into routine clinical practiceBuilds on CE mark approval in record time, underpinned by positive EU pivotal trial dataIntroduces a first-of-its-kind living vascular access solution for patients requiring hemodialysis EINDHOVEN, The Netherlands, July 07, 2026 (GLOBE NEWSWIRE) — Xeltis, a leading developer of transformative implants that enable the natural creation of living and long-lasting vessels, announced today the official start of the European commercialization of aXess™, marked by the successful treatment of the first commercial patient by Dr Dominik Liebetrau at Artemed Klinikum Munich South, Germany. aXess™ represents a new category of vascular access. Implanted in a single procedure and based on Nobel Prize-winning supramolecular science, the medical device initially serves as a scaffold ready for cannulation before gradually transforming into each patient’s own living vessel, for long-term, reliable vascular access. The commercial launch follows positive 12-month European pivotal data demonstrating secondary patency comparable to matured arteriovenous fistulas (AVFs), alongside lower reintervention rates and high infection resistance compared with historical arteriovenous graft (AVG) benchmarks. It marks the beginning of Xeltis’ broader European rollout of aXess™, providing more physicians and patients with a differentiated vascular access solution that has the potential to transform the hemodialysis treatment landscape. Dr. Dominik Liebetrau, Head of Vascular Surgery at Artemed Klinikum Munich South, Germany, said: “aXess™ integrated seamlessly into our existing surgical workflow, making adoption straightforward for our team. It offers a fundamentally new approach to vascular access – providing an implant that is designed to transform into the patient’s own living vessel. This provides physicians with a valuable new option for patients requiring long-term hemodialysis access and has the potential to improve treatment outcomes and quality of life.” Eliane Schutte, Chief Executive Officer, Xeltis, added: “The first commercial implantation of aXess™ marks the transition from clinical development into routine patient care. It is an important milestone for Xeltis and the beginning of our European commercial launch, bringing a new treatment option to patients and physicians, while building the foundation for broader adoption across Europe and, ultimately, the U.S.” Elmar Horn, Vice President of Commercial, Xeltis, said: “Our first commercial implant is a significant milestone for Xeltis and reflects the commitment of our team and our physician partners. Our focus now is on supporting participating centers as they adopt aXess™, delivering a positive experience for patients and physicians, and responsibly expanding patient access across Germany and Europe.” Peter A. Schneider, Member of the Medical Advisory Board, Xeltis commented: “This is the first time we have access to a non-autologous conduit designed to become the patient’s own vessel over time through vascular cell in-growth and tissue regeneration, ultimately behaving more like an autologous vessel. This approach has the potential to address a significant unmet need in vascular access by combining fast availability for cannulation with the long-term benefits of a living vessel.” Alongside European commercialization, Xeltis continues enrollment in its US pivotal trial of aXess™, now exceeding 50% enrollment. The study builds on the positive European pivotal data and supports the Company’s broader global commercialization strategy. Contacts XeltisEliane Schutte, CEOAlexander Goemans, CFOinfo@xeltis.com Optimum Strategic CommunicationsNick Bastin, Eleanor Cooper, Aoife Minihan +44 (0) 208 078 4357xeltis@optimumcomms.com   About XeltisXeltis is a medtech company developing transformative implants that enable the natural creation of living and long-lasting vessels. Xeltis seeks to address the limitations of currently available options for the millions of people requiring hemodialysis access grafts or cardiovascular replacements every year. The Company’s proprietary Restorex® platform utilizes an advanced polymer implant which transforms to the patient’s own tissue before gradually being absorbed and leaving new, living and long-lasting vessels in place. Xeltis’ most advanced product currently under commercial launch is aXess™, an implantable blood vessel for hemodialysis vascular access. Xeltis’ groundbreaking technology has high potential to be applied to other major vascular and cardiovascular diseases. Xeltis is based in The Netherlands and the USA. Its investors include DaVita Venture Group, EQT Life Sciences, Kurma Partners, VI Partners, Ysios Capital, Grand Pharma Group, the European Innovation Council and Invest-NL, in addition to other public and private investors. Visit the Xeltis website for more details: https://xeltis.com/

GuideAI Health Appoints Renowned Interventional Radiologist Dr. James Benenati to Advisory Board Following FDA 510(k) Clearance of VAOT

Leading Vascular Specialist and Penumbra Chief Medical Officer Joins GuideAI to Help Advance Its Recently FDA-Cleared VAOT Triage SoftwareBOSTON, July 06, 2026 (GLOBE NEWSWIRE) — GuideAI Health Corp. (Cboe CA: GDAI) (“GuideAI” or the “Company”) recently received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for VascularAssist Occlusion Triage (VAOT) (please see news release dated June 22nd, 2026), the Company’s artificial intelligence software designed to support the prioritization and triage of vascular occlusion in the lower extremities. Building on this milestone, the Company is pleased to announce the appointment of James F. Benenati, MD, FSIR, a board-certified interventional radiologist and recognized leader in vascular medicine, to its Advisory Board. Dr. Benenati brings more than three decades of clinical, research, and industry leadership in vascular care to support GuideAI’s mission of detecting vascular disease earlier and improving treatment precision through artificial intelligence. VAOT is a Class II, AI-based Software as a Medical Device (SaMD) operating as a Computer-Aided Triage and Notification device (CADt). The software aims to assist radiologists in identifying and characterizing peripheral arterial disease (PAD), a leading contributor to both acute and chronic limb ischemia, by flagging suspected vascular occlusion for prioritized review within existing imaging workflows. By surfacing high-priority cases earlier, VAOT is designed to help clinical teams reduce time to diagnosis and intervention for patients at risk of limb-threatening disease. Dr. Benenati currently serves as Chief Medical Officer of Penumbra, Inc., where he also oversees the company’s clinical research efforts. Prior to that, he practiced interventional radiology at the Miami Cardiac & Vascular Institute at Baptist Hospital for 31 years, including roles as medical director of the noninvasive vascular laboratory and fellowship program director. He is a clinical professor of radiology at the Florida International University Herbert Wertheim College of Medicine and a collaborative professor of radiology at the University of South Florida Morsani College of Medicine. A past President of the Society of Interventional Radiology (SIR), Dr. Benenati has received the SIR Gold Medal and the Charles T. Dotter Award, and has authored more than 150 scientific publications and book chapters. “Vascular disease remains one of the most underdiagnosed and costly health challenges we face, and far too many cases are caught only after serious harm has been done,” said Dr. Benenati. “GuideAI is tackling this problem at its root by bringing AI-powered early detection into routine imaging workflows. I’m excited to support a team working to give clinicians the tools to identify disease sooner and guide patients toward the right treatment.” Raj Shah, MD, MBA, Chief Executive Officer of GuideAI Health, commented, “We are honoured to welcome Dr. Benenati to our Advisory Board. As one of the most respected voices in interventional radiology and vascular care, his clinical expertise, research leadership, and deep understanding of the treatment landscape will be invaluable as we advance our platform.” About GuideAI Health Corp. GuideAI Health Corp. is a healthcare technology company using artificial intelligence to enable the early detection of vascular disease and support more precise treatment decisions. Its platform analyzes routine CT scans to identify peripheral vascular disease. By surfacing disease earlier, GuideAI aims to improve patient outcomes while helping hospitals and radiology groups deliver more comprehensive vascular care. For more information, please visit www.guideaihealth.com. On Behalf of the Board of Directors: Raj Shah CEO Contact: Phone: (416) 309-3583Email: info@guideaihealth.com Cautionary Note Regarding Forward-Looking Statements This news release contains certain “forward-looking statements” and “forward-looking information” within the meaning of applicable Canadian securities laws. Forward-looking statements include, but are not limited to, the intended design and use of VAOT and the Company’s vision. These statements are based on assumptions and expectations that management considers reasonable as of the date of this release. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied. Such factors include, among others, the risks described in the Company’s public disclosure documents available under its profile on SEDAR+ at www.sedarplus.ca. Readers are cautioned not to place undue reliance on forward-looking statements. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Cboe Canada has not reviewed, approved, or disapproved the contents of this news release, and does not accept responsibility for the adequacy or accuracy of this release.

3-Year DETOUR2 Results Demonstrate Sustained Symptom Relief and Limb Preservation in Complex SFA Disease

SANTA ROSA, Calif.–(BUSINESS WIRE)–Endologix LLC, a privately held, global medical device company focused on advancing innovative therapies for the interventional treatment of vascular disease, today announced publication of 36-month results from the DETOUR2 clinical trial evaluating Percutaneous Transmural Arterial Bypass (PTAB) using the DETOUR™ System in the Journal of the Society for Cardiovascular Angiography and Interventions (JSCAI).The DETOUR2 Trial is a prospective, single-arm, intern

CorVista Health Announces New AMA Category III CPT® Code for Augmentative AI Analysis of Cardiopulmonary Disease

BETHESDA, Md.–(BUSINESS WIRE)–CorVista Health, has announced that the American Medical Association (AMA) has granted a new Category III Current Procedural Terminology (CPT®) code for novel augmentative AI algorithmic analysis of potential coronary artery disease (CAD), pulmonary hypertension (PH), and elevated pulmonary capillary wedge pressure (PCWP). The new code encompasses the FDA-cleared CorVista® System for CAD and PH, as well as the anticipated PCWP Add-On algorithm which is currently