Coronary/Structural Heart

Elucid Announces First Patient Enrollment in AI-PREDICT, a Landmark International Study to Define Lesion-Level Cardiovascular Risk

BOSTON–(BUSINESS WIRE)– #Atherosclerosis–Elucid, an innovator in AI-powered coronary CT angiography (CCTA) analysis, today announced first patient enrollment in AI-PREDICT, a retrospective, international, multicenter study designed to establish a new lesion-centric paradigm for cardiovascular risk stratification. Enrollment is underway at three of more than 20 planned sites across the U.S., Europe, and Asia: Emory University, the Medical University of South Carolina, and Centro Cardiologico Monzino, Milan, led

Cardiac Dimensions® Announces Three Major Publications Demonstrating Long-Term Durability, Real-World Performance, and Broad Patient Benefit of the Carillon Mitral Contour System®

KIRKLAND, Wash.–(BUSINESS WIRE)–Cardiac Dimensions, a leader in transcatheter therapies for heart failure, today announced the publication of three major manuscripts that together form the most comprehensive evidence base ever assembled for transcatheter indirect mitral annuloplasty. These publications span a five-year multi-center commercial registry, the largest single-center experience across both preserved and reduced ejection fraction, and long-term survival results through ten years. Th

Conavi Medical Announces JSCAI Publication Demonstrating the Clinical Utility of Hybrid IVUS OCT Imaging

Publication demonstrates how complementary IVUS and OCT information supports lesion assessment, treatment planning, and stent optimization while helping manage contrast useTORONTO, July 08, 2026 (GLOBE NEWSWIRE) — Conavi Medical Corp. (TSXV: CNVI) (OTCQB: CNVIF) (“Conavi” or the “Company”), a commercial-stage medical device company focused on designing, manufacturing, and marketing imaging technologies to guide minimally invasive cardiovascular procedures, today announced the publication of a case report in the Journal of the Society for Cardiovascular Angiography & Interventions (“JSCAI”) titled “Versatility of Hybrid OCT and IVUS Imaging Enhances Contrast-Sparing Management of Eruptive Calcified Nodules.” The publication features Conavi’s hybrid intravascular ultrasound (“IVUS”) and optical coherence tomography (“OCT”) imaging system in a complex coronary procedure involving a patient with impaired renal function, where managing contrast exposure was an important consideration. The publication follows Conavi’s April 20, 2026 announcement that it received U.S. Food and Drug Administration (“FDA”) 510(k) clearance for its next-generation hybrid IVUS-OCT imaging system. “Following our recent FDA clearance, we are focused on advancing the commercial rollout of Conavi’s hybrid IVUS-OCT imaging system and building the clinical evidence to support adoption,” said Thomas Looby, President and Chief Executive Officer of Conavi Medical. “This JSCAI case report demonstrates the practical value of having IVUS and OCT available through a single hybrid system to assess complex lesions, support treatment planning and help manage contrast use during image-guided PCI.” “Hybrid imaging gave us the ability to use OCT when its higher resolution was most useful, while relying on IVUS-only imaging to reduce contrast exposure during the procedure,” said Dr. Megha Prasad, co-author of the publication and interventional cardiologist. “The co-registered view supported complete lesion assessment (obtaining information on calcium, thrombus, vessel size and the final stent result), leveraging the individual benefits of each imaging modality.”“This approach fundamentally changed how we made decisions during the procedure. Rather than being locked into a single imaging modality from the outset, we could select the imaging technique that best served the patient at each stage of the case. That flexibility allowed us to adapt in real time without compromising on patient care.” The case report highlights several practical advantages of Conavi’s hybrid IVUS-OCT imaging, including the ability to: use OCT’s high-resolution imaging to help visualize thrombus overlying the calcified nodule;use IVUS to delineate the calcium arc and support lesion assessment;toggle between hybrid imaging and IVUS-only pullbacks during the procedure;support stent optimization while limiting contrast exposure in a patient with impaired renal function. The procedure demonstrated how OCT could be used selectively when high-resolution imaging was needed, while IVUS-only imaging was relied upon during other stages of the intervention to help minimize contrast exposure in a patient with impaired renal function. The authors noted that diagnosing eruptive calcified nodules can be challenging when using IVUS or OCT alone, due to the individual limitations of each imaging modality, particularly in patients with impaired renal function. The publication concluded that hybrid IVUS-OCT imaging may play an important role in patients with challenging plaque morphology, especially in the setting of chronic kidney disease. The publication, published online in July 2026, can be accessed at: https://www.jscai.org/article/S2772-9303(26)01244-5/fulltext. About Conavi Medical Conavi Medical is focused on designing, manufacturing, and marketing imaging technologies to guide common minimally invasive cardiovascular procedures. Its patented hybrid imaging system is the first system to co-register and co-align intravascular ultrasound (IVUS) and optical coherence tomography (OCT) imaging beams to enable simultaneous hybrid imaging of coronary arteries. The hybrid imaging system has 510(k) clearance from the U.S. Food and Drug Administration. For more information, visit http://www.conavi.com/. Notice on forward-looking statementsThis 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 commercialization and commercial launch of Conavi’s hybrid imaging system and the timing thereof, the sufficiency of Conavi’s resources to achieve such commercial launch, the global market opportunity for coronary intravascular imaging (including for IVUS and OCT), the continued growth in adoption of and in the clinical validation and guideline support for intravascular imaging and the ability of Conavi’s hybrid imaging system to meet market needs. 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” 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 annual information form of the Company dated February 26, 2026 (available 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. CONTACT:Chief Financial Officer: Mark Quick, 416-483-0100Investors: Christina Cameron, 416-483-0100 ext.121, IR@conavi.com

Caristo Diagnostics to Highlight New Findings Reinforcing the Science of Its Coronary Inflammation and Plaque Analysis Technologies at SCCT 2026

Three of six SCCT 2026 Young Investigator Award-nominated abstracts utilize Caristo’s technologies, including—for the first time—an application of FAI-Score on non-contrast cardiac CT OXFORD, England and STAMFORD, Conn., July 8, 2026 /PRNewswire/ — Caristo Diagnostics, a global leader in…

Nyra Medical Announces First Patient Enrollment in ENHANCE Early Feasibility Study, Advancing Next Generation Mitral Valve Repair Platform

Global clinical program expands to the United States and Brazil following successful First-in-Human experience, marking a major milestone in development of the CARLEN™ System ATLANTA, July 7, 2026 /PRNewswire/ — Nyra Medical, Inc., a clinical-stage medical technology company developing a novel transcatheter solution for functional mitral regurgitation (FMR), today announced enrollment of […]

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

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

Amarin Reaffirms the Proven, Guideline-Recommended Role of VASCEPA® (Icosapent Ethyl) in an Evolving Triglyceride Treatment Landscape 

Clinically Validated, Increasingly Prescribed, Widely Reimbursed, and Affordable, VASCEPA Expected to Benefit from Increased Attention to Patients with Severely Elevated TriglyceridesDUBLIN, Ireland and BRIDGEWATER, N.J., June 30, 2026 (GLOBE NEWSWIRE) — Amarin Corporation plc (NASDAQ: AMRN), a company committed to advancing the science of cardiovascular disease worldwide, applauds the recent FDA approval of injectable apolipoprotein C-III (APOC3) therapies for the treatment of severe hypertriglyceridemia (sHTG), defined as triglycerides (TG) greater than or equal to 500 mg/dL.i These injectable therapies represent meaningful progress for patients at high risk for serious, sometimes life-threatening diseases associated with sHTG, including acute pancreatitis. “The renewed attention triglycerides generated by the introduction of innovative therapies is welcome, as they help to drive patient–physician conversations and bring critical awareness to the dangers of very high triglyceride levels,” said Aaron Berg, CEO of Amarin. “We recognize the important therapeutic advancement that APOC3 therapies represent and are optimistic about their potential benefit in patients at high risk of acute pancreatitis. For many years, clinicians have managed sHTG with proven, foundational therapies like VASCEPA, which remains a critical, first-line option for millions of individuals who have taken control of their lipid management. We remain mindful that issues such as cost, coverage, and accessibility may influence how and when patients are able to benefit from innovative, yet high-cost therapies. Therefore, we are confident that VASCEPA will continue to deliver strong clinical and economic value for a broad segment of patients with severe hypertriglyceridemia.” Mr. Berg noted the following: Robust Reductions in sHTG Without LDL-C Increases: VASCEPA has been shown to deliver a 33% median reduction in TG levels in patients with sHTG as compared to placebo, with approximately 50% of patients achieving TG levels below 500 mg/dL at 12 weeks.ii,iii These reductions were achieved without the increases in LDL cholesterol observed with certain other triglyceride-lowering agents in patients with sHTG.iv,v,vi   Lower Cost, Proven Efficacy, and Broad Access: There is a stark contrast in cost between VASCEPA and recently introduced injectable APOC3 therapies, the most recent of which carries an annual wholesale acquisition cost (WAC) of $40,000 per patient. By comparison, the annual wholesale acquisition cost for VASCEPA is approximately $4,200 per patient. Reflecting this cost differential, many payers, pharmacy benefit managers (PBMs), and managed care organizations may follow a well-established pattern of managing utilization of premium priced therapies through judicious prior authorization and step-therapy requirements.vii   Elevated Triglyceride Patients are at Increased Risk for Cardiovascular Disease: VASCEPA has been prescribed more than 30 million times globally for patients with elevated triglycerides and remains the first and only FDA-approved therapy proven to reduce the risk of cardiovascular events by 25% when added to a statin in high-risk patients with elevated triglycerides and other cardiovascular risk factors.viii   Global Guideline Support Recently Reaffirmed: 70+ leading medical societies recognize the importance of icosapent ethyl based on the strength of the clinical data. The 2026 American College of Cardiology / American Heart Association / Multisociety Dyslipidemia Guideline reaffirmed the role of established triglyceride-lowering therapies, including VASCEPA, in the management of patients with elevated triglycerides.i Mr. Berg concluded, “We fully appreciate the potential benefits of recently introduced therapies for the segment of sHTG patients who are at high risk of acute pancreatitis. However, for the majority of the sHTG patient population, and for the broader global population of patients with elevated triglycerides at risk for cardiovascular events, significant clinical and economic value will be derived from prioritizing treatments such as VASCEPA that are proven, safe, commonly prescribed, affordable, and widely reimbursed.” About Amarin  Amarin is a global pharmaceutical company committed to reducing the cardiovascular disease (CVD) burden for patients and communities and to advancing the science of cardiovascular care around the world. We own and support a global branded product approved by multiple regulatory authorities based on a track record of proven efficacy and safety and backed by robust clinical trial evidence. Our commercialization model includes a direct sales approach in the U.S. and an indirect distribution strategy internationally, through a syndicate of reputable and well-established partners with significant geographic expertise, covering close to 100 markets worldwide. Our success is driven by a dedicated, talented, and highly skilled team of experts passionate about the fight against the world’s leading cause of death, CVD.  About VASCEPA®/VAZKEPA® (icosapent ethyl) Capsules  VASCEPA (icosapent ethyl) capsules are the first prescription treatment approved by the U.S. Food and Drug Administration (FDA) comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. VASCEPA was launched in the United States in January 2020 as the first drug approved by the U.S. FDA for treatment of the studied high-risk patients with persistent cardiovascular risk despite being on statin therapy. VASCEPA was initially launched in the United States in 2013 based on the drug’s initial FDA approved indication for use as an adjunct therapy to diet to reduce triglyceride levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia. Since launch, VASCEPA has been prescribed more than thirty million times. VASCEPA is covered by most major medical insurance plans. In addition to the United States, VASCEPA is approved and sold in Canada, China, Australia, Lebanon, the United Arab Emirates, Saudi Arabia, Qatar, Bahrain, and Kuwait. In Europe, in March 2021 marketing authorization was granted to icosapent ethyl in the European Union for the reduction of risk of cardiovascular events in patients at high cardiovascular risk, under the brand name VAZKEPA. In April 2021 marketing authorization for VAZKEPA was granted in the United Kingdom (applying to England, Scotland, Wales, and Northern Ireland). VAZKEPA is currently approved and sold in Europe in Sweden, Finland, England/Wales, Spain, Netherlands, Scotland, Greece, Portugal, Italy, Denmark and Austria.  United States Indications and Limitation of Use VASCEPA is indicated:   As an adjunct to maximally tolerated statin therapy to reduce the risk of myocardial infarction, stroke, coronary revascularization and unstable angina requiring hospitalization in adult patients with elevated triglyceride (TG) levels (≥ 150 mg/dL) and established cardiovascular disease or diabetes mellitus and two or more additional risk factors for cardiovascular disease.  As an adjunct to diet to reduce TG levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. The effect of VASCEPA on the risk for pancreatitis in patients with severe hypertriglyceridemia has not been determined.  Important Safety Information  VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.VASCEPA was associated with an increased risk (3% vs 2%) of atrial fibrillation or atrial flutter requiring hospitalization in a double-blind, placebo-controlled trial. The incidence of atrial fibrillation was greater in patients with a previous history of atrial fibrillation or atrial flutter.It is not known whether patients with allergies to fish and/or shellfish are at an increased risk of an allergic reaction to VASCEPA. Patients with such allergies should discontinue VASCEPA if any reactions occur.VASCEPA was associated with an increased risk (12% vs 10%) of bleeding in a double-blind, placebo-controlled trial. The incidence of bleeding was greater in patients receiving concomitant antithrombotic medications, such as aspirin, clopidogrel or warfarin.Common adverse reactions in the cardiovascular outcomes trial (incidence ≥3% and ≥1% more frequent than placebo): musculoskeletal pain (4% vs 3%), peripheral edema (7% vs 5%), constipation (5% vs 4%), gout (4% vs 3%), and atrial fibrillation (5% vs 4%).Common adverse reactions in the hypertriglyceridemia trials (incidence >1% more frequent than placebo): arthralgia (2% vs 1%) and oropharyngeal pain (1% vs 0.3%).Adverse events may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.Patients receiving VASCEPA and concomitant anticoagulants and/or anti-platelet agents should be monitored for bleeding. FULL U.S. FDA-APPROVED VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM. Europe  For further information about the Summary of Product Characteristics (SmPC) for VAZKEPA® in Europe, please visit: https://www.ema.europa.eu/en/documents/product-information/vazkepa-epar-product-information_en.pdf   Globally, prescribing information varies; refer to the individual country product label for complete information. Forward-Looking Statements  This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including beliefs about Amarin’s outlook for achievements in 2026 and beyond; Amarin’s overall efforts to expand access and reimbursement to VASCEPA/VAZKEPA across global markets; expectations regarding potential market dynamics, payer behavior, and the competitive landscape; and the overall potential and future success of VASCEPA/VAZKEPA and Amarin that are based on the beliefs and assumptions and information currently available to Amarin. All statements other than statements of historical fact contained in this press release are forward-looking statements. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. A further list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including Amarin’s annual report on Form 10-K for the fiscal year ended 2025 and subsequent quarterly reports on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date they are made. Amarin undertakes no obligation to update or revise the information contained in its forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.  Amarin Contact Information   Media Inquiries:  Tegan Berry  Amarin Corporation plc  PR@amarincorp.com   Investor Inquiries: Devin Sullivan & Conor Rodriguez  The Equity Group on Behalf of Amarin   devin.sullivan.ext@amarincorp.com or conor.rodriguez.ext@amarincorp.com Investor.relations@amarincorp.com  i Blumenthal RS, Morris PB, Gaudino M, et al. 2026 ACC/AHA/AACVPR/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA Guideline on the Management of Dyslipidemia: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2026 Mar 13:S0735-1097(25)10254-4. doi: 10.1016/j.jacc.2025.11.016. Epub ahead of printii Bays HE, et al. Am J Cardiol. 2011;108(5):682-90. doi: 10.1016/j.amjcard.2011.04.015.iii Chowdhury IN. Medical Review(s): Vascepa (Icosapent Ethyl). Silver Spring, MD: US Food and Drug Administration; 2012:50. Application No. 202057Orig1s000. Accessed December 17, 2025. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/202057Orig1s000MedR.pdfiv https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=21cfa4ce-0b05-47ed-b268-339eb1b83b75 v https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022224s018lbl.pdf vi Marston NA, Bergmark BA, Alexander VJ, et al.; CORE-TIMI 72a and CORE2-TIMI 72b Investigators. Olezarsen for managing severe hypertriglyceridemia and pancreatitis risk. N Engl J Med. 2025 Nov 8. doi: 10.1056/NEJMoa2512761. vii Annual wholesale acquisition cost: published WAC pricing / data on file. [Medi-Span® Price Rx Pro®”]viii Bhatt DL, Steg PG, Miller M, et al., on behalf of the REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019;380:11-22. DOI: 10.1056/NEJMoa1812792