The Latest Cardiac and Vascular News
Next-generation DICOM SR integration is critical for the success of generative AI reporting. PLEASANTON, Calif., May 28, 2026 /PRNewswire/ — Altamont Software, a provider of enterprise medical connectivity solutions, today announced a surge in replacements for DICOM Structured Reporting…
SANTA CLARA, Calif.–(BUSINESS WIRE)–Coredio, a digital health company developing the first software-as-a-medical-device (SaMD) platform dedicated to heart failure (HF) hemodynamic assessment, today announced that the U.S. Food and Drug Administration has granted its Cardiac Performance Simulation Engine (CPSE™) Breakthrough Device Designation and accepted the platform into the FDA’s Total Product Life Cycle Advisory Program (TAP). CPSE™ is a software-only platform designed to deliver catheter
Submission Anticipated in Q4 2026SUNNYVALE, Calif., May 28, 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 reported the Consultation Record from Japan’s Pharmaceutical and Medical Device Agency (PMDA) supports submission for regulatory approval of the CardiAMP® cell therapy for the treatment of ischemic heart failure of reduced ejection fraction (HFrEF) based on the Company’s three completed clinical trials of this therapy in HFrEF. PMDA’s Consultation Record confirms alignment on remaining questions to address before, and as part of the submission, for regulatory approval for ischemic HFrEF patients with elevated biomarkers of heart stress (NTproBNP) on stable guideline directed medical therapy (GDMT). PMDA noted that the positive outcomes seen in the trial were credible. It is estimated that 20,000 of the 300,000 patients in Japan would initially be eligible for this therapy. PMDA requested BioCardia demonstrate that enrolled patients were on GDMT and not eligible for revascularization procedures, required per CardiAMP HF protocol, and provide additional details for each incidence of all-cause death, heart transplantation or left ventricular assist device implantation. “PMDA’s recognition of the urgent unmet clinical need in HFrEF and their support of this novel therapy is valued,” said BioCardia Chief Executive Dr. Peter Altman. “We believe the clinical package prepared for this submission will be sufficient to support approval.” As part of the submission review for approval of CardiAMP Cell Therapy, the Agency requests post-marketing study plans including the criteria for patient selection, the clinical decision-making framework, and appropriate medical infrastructure and specialist involvement. BioCardia has been guided to collaborate with relevant Japanese academic societies to establish proper-use guidelines and sufficiently consider product training, proctoring, and post market surveillance. BioCardia’s timeline for PMDA submission is seven months. BioCardia plans to submit with a Designated Marketing Authorization Holder as the optimal pathway for regulatory submission, regulatory review, and to initiate commercialization of the CardiAMP Cell Therapy System while conducting the post market study in Japan. The PMDA review process will be rigorous, and BioCardia believes the documentation to support review is in good shape. BioCardia is ISO13485 compliant for the design, manufacture, and distribution of medical devices for cardiovascular procedures, including catheters for use in delivery of therapeutic agents directly to the heart, and currently manufactures FDA cleared products. When PMDA concludes its technical assessment and recommends approval, the Ministry of Health, Labour and Welfare (MHLW) ultimately issues the certificate enabling commercialization. About CardiAMP Autologous Cell TherapyGranted 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. 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. 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 CardiAMP Cell Therapy by PMDA. 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, Marketing / Investor RelationsEmail: mpeto@BioCardia.comPhone: 650-226-0120 Investor Contact:David McClung, Chief Financial OfficerEmail: investors@BioCardia.comPhone: 650-226-0120
– Achieves U.S. FDA 510(k) Clearance for Next-Generation Hybrid IVUS-OCT Imaging System- Wins Multiple Industry Awards Recognizing Innovation and Leadership in Intravascular Imaging- Advances U.S. Commercial Readiness and Launch Financing Initiatives TORONTO, May 28, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today reported financial results and provided an operational update for the fiscal quarter ended March 31, 2026 (“Fiscal Q2 2026”). “Fiscal Q2 2026 marked a transformational period for Conavi highlighted by FDA 510(k) clearance of our next-generation Novasight™ Hybrid system, a milestone that positions the Company for commercial launch in the United States,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “In addition to this significant regulatory achievement, we were honoured to receive multiple industry awards recognizing the innovation and clinical potential of our hybrid IVUS-OCT technology. With commercialization activities advancing and financing initiatives underway to support our U.S. launch strategy, we believe Conavi is entering an exciting new phase of growth.” Fiscal Q2 2026 Business and Operational Highlights FDA 510(k) Clearance of Next-Generation Hybrid Imaging SystemOn April 20, 2026, subsequent to quarter end, Conavi announced that it received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its next-generation hybrid intravascular imaging system. The system integrates intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) into a single platform designed to provide simultaneous, co-registered imaging of coronary arteries within a unified workflow. The Company believes the clearance represents a major milestone for Conavi and positions the Company to initiate its targeted U.S. commercial launch expected in calendar H2 2026. The next-generation system includes enhancements designed to improve image quality, workflow efficiency, catheter deliverability, and overall ease of use for physicians performing image-guided coronary interventions. Industry Awards Recognize Innovation and Technology LeadershipDuring and subsequent to the quarter, Conavi received multiple industry recognitions highlighting the Company’s innovation in intravascular imaging technology. Conavi was named a winner in the Medical Device category at the 2026 MedTech Breakthrough Awards, an independent program recognizing leading companies and technologies in the global health and medical technology market. The award recognized Conavi’s next-generation hybrid IVUS-OCT imaging platform and its potential to improve physician workflow and clinical decision-making during coronary interventions. Conavi was also awarded a 2026 TAG Innovation Award recognizing innovation and leadership in advancing healthcare technology following the Company’s recent FDA 510(k) clearance announcement. Management believes these recognitions provide important third-party validation of Conavi’s technology and commercial opportunity within the growing intravascular imaging market. Commercial Readiness Activities ContinueFollowing FDA clearance, Conavi is focused on commercial readiness initiatives to support targeted U.S. market release activities in calendar H2 2026. Activities underway include manufacturing transfer and scale-up, reliability studies, inventory build, physician training preparation, and engagement with select U.S. clinical centers. The Company continues to believe that growing clinical evidence supporting intravascular imaging, combined with increasing physician adoption of image-guided PCI procedures, supports a significant long-term market opportunity for hybrid IVUS-OCT imaging technology. Participation in Healthcare Investor ConferenceDuring the quarter, Conavi announced participation in the 2026 Bloom Burton & Co. Healthcare Investor Conference, where management presented updates regarding the Company’s commercialization strategy and regulatory progress. Proposed Public Offering to Support U.S. Commercial LaunchOn May 11, 2026, subsequent to quarter end, Conavi announced a proposed public offering of common shares and/or pre-funded warrants pursuant to a preliminary short form prospectus filed in Canada. The Company intends to use the net proceeds from the offering to support a limited market release in the United States, working capital requirements, and general corporate purposes. OutlookWith FDA 510(k) clearance now secured, Conavi is focused on executing the next phase of its commercialization strategy, including manufacturing scale-up and targeted U.S. market release activities expected to begin in calendar H2 2026. Fiscal Q2 2026 Financial HighlightsAll amounts are in Canadian dollars unless otherwise noted. Licensing and R&D services revenue for Fiscal Q2 2026 was $0.1 million compared to $0.1 million in the prior-year period. For the six months ended March 31, 2026, total revenue was $0.3 million compared to $8.7 million in the prior-year period, which included milestone revenue under a development agreement that did not recur in Fiscal 2026. Total operating expenses for Fiscal Q2 2026 were $4.7 million compared to $5.6 million in Fiscal Q2 2025, reflecting lower research and development expenses as the Company progressed beyond intensive development phases, partially offset by increased commercialization and corporate activities supporting anticipated U.S. launch preparations. Net loss for Fiscal Q2 2026 was $4.8 million, compared to a net loss of $3.1 million in the prior-year period. For the six months ended March 31, 2026, net loss was $7.5 million compared to $10.2 million in the prior-year period. Cash and cash equivalents were $4.5 million as of March 31, 2026, compared to $5.8 million as of September 30, 2025. For additional information regarding the Company’s financial performance, including management’s discussion and analysis, readers are encouraged to review Conavi Medical’s filings on SEDAR+ and on the Company’s website at www.conavi.com. About Conavi MedicalConavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented Novasight Hybrid™ platform is the first to combine intravascular ultrasound (IVUS) and optical coherence tomography (OCT) into a single system, enabling simultaneous and co-registered imaging of coronary arteries. Conavi recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for its next-generation hybrid intravascular imaging system, designed to support physician decision-making and workflow efficiency during image-guided coronary interventions. For more information, visit conavi.com. CONTACT:Chief Financial Officer: Mark Quick, 416-483-0100Investors: Christina Cameron, 416-483-0100 ext.121, IR@conavi.com Notice on forward-looking statements:This press release includes forward-looking information or forward-looking statements within the meaning of applicable securities laws regarding the Company and its business, which may include, but are not limited to, statements with respect to the anticipated terms and jurisdictions of the Offering; the securities offered thereunder; the timing of the Offering; the use of proceeds from the Offering; Conavi’s plans for the commercialization of its next-generation hybrid intravascular imaging system, including the commercial launch of next-generation hybrid intravascular imaging system in the U.S. and the timing thereof; the sufficiency of Conavi’s capital resources to achieve such commercial launch; continued growth in the clinical validation and guideline support for intravascular imaging; increasing physician adoption of image-guided PCI procedures; and the ability of Conavi’s next-generation hybrid imaging system to meet market need. All statements that are, or information which is, not historical facts, including without limitation, statements regarding future estimates, plans, programs, forecasts, projections, objectives, assumptions, expectations or beliefs of future performance, are “forward-looking information or statements”. Often but not always, forward-looking information or statements can be identified by the use of words such as “shall”, “intends”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate” “anticipate” or any variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “might”, “can”, “could”, “would” or “will” be taken, occur, lead to, result in, or, be achieved. Such statements are based on the current expectations and views of future events of the management of the Company. They are based on assumptions and subject to risks and uncertainties. Although management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this release, may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting the Company, including, without limitation, those listed in the “Risk Factors” section of the Preliminary Prospectus and the “Risk Factors” section of the annual information form of the Company for the year ended September 30, 2025 (both of which are on the Company’s profile at www.sedarplus.ca). Although the Company has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. Accordingly, readers should not place undue reliance on any forward-looking statements or information. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. No regulatory authority has approved or disapproved the content of this press release. Neither the TSX Venture Exchange nor its Regulatory Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.606546396v.1
Repairon Announces Publication of Clinical Trial Results for Engineered Human Heart Muscle Tissue in the New England Journal of MedicineGÖTTINGEN, Germany and PROVIDENCE, R.I., May 28, 2026 (GLOBE NEWSWIRE) — Repairon, a biotechnology company developing regenerative cardiac therapies, today announced that clinical results evaluating its engineered human heart muscle tissue for patients with advanced heart failure have been published in the New England Journal of Medicine (NEJM). The publication concludes that restoration of heart muscle function in patients with advanced heart failure is achievable, resulting in improved health and quality of life. Publication details: Zimmermann WH, Ensminger S, Kutschka I, et al. Stem-Cell-Derived Biologic Ventricular Assist Tissue in Heart Failure. N Engl J Med. May 28;394(20):1991-2001 DOI: 10.1056/NEJMoa2513525 The data were generated in the BioVAT-HF clinical trial (BiologicalVentricularAssistTissue in TerminalHeartFailure). Designed to assess safety and preliminary efficacy, this Phase 1-2 study involved implanting fully functional heart muscle patches engineered from human induced pluripotent stem cell-derived terminally differentiated heart muscle cells onto the weakened left ventricular muscle of patients with advanced heart failure with reduced ejection fraction (HFrEF), alongside guideline-directed medical therapy. The trial began with a dose-escalation phase to establish the safe maximum dose, followed by treatment at that dose to further evaluate safety and efficacy. Of the 20 patients enrolled, 16 received the safe maximum dose. At the time of reporting, the last enrolled patient had completed 3 months of follow-up, and follow-up across these patients ranged from 6 to 52 months. Key safety findings from the NEJM Publication indicate that 3 patients died during the trial from causes that the Data Safety Monitoring Board graded as unrelated to the BioVAT. Severe adverse events were mostly related to underlying heart and concurrent diseases as well as to immunosuppression requiring adaptation of the immunosuppression regimen. 3 patients experienced episodes of ventricular tachycardia which were found to be unrelated to the BioVAT transplant. No patients had ventricular fibrillation. Among the 16 safe maximal dose patients, there were heart failure hospitalizations for 2 patients. The efficacy findings from the NEJM Publication indicate that for those patients who received the safe maximal dose, from baseline: Target heart wall thickness increased 4.5 mm at 3 months and 2.9 mm at 12 months follow-up.Left ventricular ejection fraction increased 3.9% at 3 months and 6.9% at the latest timepoint.Quality of Life as measured by KCCQ-OSS increased 6.7 points at 3 months and 15 points at 12 months follow-up. The study outcomes support preclinical findings that engineered heart muscle can integrate with damaged myocardium, form a vascularized layer, and contract in synchrony with native tissue. This was further confirmed by analysis of an explanted heart from a patient in the dose-finding cohort who later underwent cardiac transplantation, providing clear evidence of human heart remuscularization and associated increases in wall thickness, ejection fraction, and quality of life. The authors concluded that further clinical investigations with longer follow-up times are warranted. Wolfram-Hubertus Zimmermann. MD, professor and director of the Institute of Pharmacology and Toxicology at the University Medical Center Goettingen, Germany, and principal author of the NEJM Publication, remarked that “heart failure therapies available today can often slow the progression of the disease, but they cannot replace destroyed heart muscle. Our goal, therefore, is to generate new, functional heart muscle tissue and thereby provide targeted support to the weakened heart.” Lothar Germeroth, Ph.D., Repairon’s CEO, stated: “We are highly encouraged by these Phase II results, which we believe validate the therapeutic potential of our regenerative cardiac patch platform. Heart failure remains one of the leading causes of morbidity and mortality worldwide, and we believe these findings may open a new chapter in myocardial regeneration and restorative cardiovascular medicine.” High medical need in advanced heart failure: Approximately 5% of the global population suffers from chronic heart failure of any severity, and it remains one of the most common causes of death. In the US, heart failure represents the most common cause of hospitalization and mortality in the senior population, and over 6 million people are affected. As heart failure progresses to advanced stages, patients experience weakness with discomfort during all physical activities and at rest, sometimes even requiring constant bed rest. For these severely ill patients, the only treatment options currently available are mechanical pump devices or heart transplantation. About Repairon: Repairon GmbH is a German biotech company based in Göttingen, Germany, focused on developing regenerative cell therapies for cardiac medicine. The company was founded in 2014 based on research by Wolfram-Hubertus Zimmermann, MD and his team at the University Medical Center Goettingen, who have developed several tissue engineering technologies with proven applicability for organ repair and drug development. Repairon’s lead therapeutic candidate, the human engineered heart muscle patch, is currently being evaluated in the BioVAT-HF Phase 2 clinical trial as a biological ventricular assist tissue (BioVAT) for end-stage heart failure. Company contact:Dr. Lothar GermerothRepairon GmbH37079 Göttingen – GermanyEmail: l.germeroth@repairon.comUS contact:Frank AhmannRepairon USAProvidence, RI Email: f.ahmann@repairon.com
International gathering of more than 1,400 vascular specialists will feature the latest data on limb-threatening diseases, novel technology and integration of specialty within larger healthcare system BOSTON, MA, MAY 27, 2026 – The Society for Vascular Surgery’s Vascular Annual Meeting (VAM) will commence on Wednesday, June 10, 2026, uniting the greatest […]
Strategic Partnership Will Fuel Growth While Maintaining Focus on Quality NORTH CANTON, Ohio, May 27, 2026 /PRNewswire/ — Captive Radiology, a leading provider of turnkey diagnostic imaging solutions, today announced a strategic growth investment from RC Capital, a healthcare-focused…
WALTHAM, Mass.–(BUSINESS WIRE)– #businesspartnership–Wolters Kluwer & RSNA sign 10-year deal to expand global access, visibility, & impact of leading radiology research journals & AI-focused titles.
IRVINE, Calif., May 27, 2026 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer and manufacturer of the Trilogy® Transcatheter Heart Valve (THV) System, today announced the appointment of Edward (Ed) Sarnowski as Chief Technology Officer. Ed will lead the company’s R&D organization and drive the next phase of innovation as JenaValve advances its transcatheter aortic valve programs following the recent U.S. FDA approval of the Trilogy THV System for symptomatic, severe aortic regurgitation (ssAR). Ed brings more than 20 years of medical device R&D leadership experience, with deep expertise in structural heart and transcatheter valve technologies. In this role, he will be instrumental in advancing JenaValve’s key innovation initiatives and expanding the Trilogy platform’s capabilities to safely and effectively serve the broadest possible population of patients suffering from aortic regurgitation. Most recently, Ed served as Vice President of R&D for TAVR and Congenital and subsequently Vice President of R&D, Mitral & Tricuspid at Medtronic Structural Heart, where he led a global R&D organization accountable for establishing transcatheter valve replacement therapies spanning R&D execution, clinical investigation, and portfolio strategy. Prior to Medtronic, Ed spent a decade at St. Jude Medical (acquired by Abbott) in senior R&D and business development leadership roles, where he drove FDA PMA submissions and built early-stage partnerships across cardiac and heart failure programs. Ed holds a Bachelor of Science in Mechanical Engineering from MIT, a Master of Science in Engineering from the University of Texas at Austin, and an MBA from MIT Sloan School of Management. “Ed’s appointment marks an important step in the evolution of JenaValve as a company,” said John Kilcoyne, Chief Executive Officer of JenaValve. “With FDA approval now behind us and the U.S. commercial launch underway, we are entering a new phase of growth that demands R&D leadership of the highest caliber. Ed’s deep experience building and scaling global R&D organizations, delivering complex transcatheter programs from concept to commercialization, and navigating the regulatory rigor required in structural heart makes him exactly the right person to lead our technology organization. I am confident that under his leadership, we will continue to advance the science of TAVR for AR.” “I am honored to join JenaValve at such a transformative moment,” said Ed Sarnowski, Chief Technology Officer of JenaValve. “The Trilogy System represents a remarkable achievement — a purpose-built, first-of-its-kind transcatheter therapy that addresses a true unmet need in the structural heart space. I look forward to working alongside this exceptional team to build on the foundation that has been established, driving the meaningful innovation required to deliver life-changing solutions to cardiovascular patients worldwide.” 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 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
CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics will exhibit at four upcoming national benefits conferences.
