NEW YORK–(BUSINESS WIRE)– #AI–Powerful Medical, a leader in AI-driven cardiovascular diagnostics, today announced that the American Medical Association (AMA) CPT® Editorial Panel has established a new Category III CPT code, 1139T, for the noninvasive identification of ST-elevation myocardial infarction (STEMI), STEMI equivalents, and acute or subacute myocardial ischemia by assistive algorithmic analysis of the electrocardiogram (ECG). This is the service performed with Queen of Hearts™, which rec
Coronary/Structural Heart
Vincora Receives FDA Approval to Initiate U.S. Early Feasibility Study of Transcatheter Chordal Repair System
MAPLE GROVE, Minn., Oct. 27, 2026 /PRNewswire/ — Vincora (NeoChord, Inc. d/b/a Vincora), a medical technology company developing transcatheter therapies for mitral valve repair, today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Investigational…
Anteris Announces Upcoming Data Release for Medium-Size DurAVR THV from EMBARK Study at TCT 2026
MINNEAPOLIS and BRISBANE, Australia, Oct. 27, 2026 (GLOBE NEWSWIRE) — Anteris Technologies Global Corp. (“Anteris” or the “Company”) (NASDAQ: AVR, ASX: AVR) today announced that Azeem Latib, MD, will present the first 30-day clinical and hemodynamic outcomes for its medium-size DurAVR® Transcatheter Heart Valve (THV) at TCT® 2026 – The 38th Annual Transcatheter Cardiovascular Therapeutics Conference, taking place in San Diego, California, October 31-November 3, 2026. The presentation will report 30-day outcomes in patients with severe aortic stenosis who received the medium-size DurAVR THV in the ongoing EMBARK study. Since 2021 over 130 patients have been treated with the DurAVR THV across different valve sizes in the Company’s EMBARK study and Early Feasibility Study (EFS). In a separate session on emerging TAVR technologies, Santiago Garcia, MD, will present “DurAVR TAVR (ANTERIS): Technology and Case-in-a-Box”, featuring the biomimetic DurAVR THV, a new class of transcatheter aortic valve replacement (TAVR). Session details are as follows: 1) TCT Innovation 3: Emerging Concepts and Innovations in TAVR Sunday, November 1, 2026, 10:45 AM – 12:15 PM PST Room: Innovation Theater The Novel Biomimetic Medium DurAVR THV Balloon-Expandable Valve (Anteris): First Report of the 30-Day Clinical and Hemodynamic Outcomes Presenter: Azeem Latib, MD 2) TCT Innovation 15: Live Case-in-a-Box Innovation: Emerging TAVR Technologies Tuesday, November 3, 2026, 8:35 – 9:35 AM PST Room: Innovation Theater DurAVR TAVR (ANTERIS): Technology and Case-in-a-Box Presenter: Santiago Garcia, MD About Anteris Anteris Technologies Global Corp. (NASDAQ: AVR, ASX: AVR) is a global healthcare company committed to designing, developing, and commercializing cutting-edge medical devices to restore healthy heart function. Founded in Australia, with a significant presence in Minneapolis, USA, Anteris is a science-driven company with an experienced team of multidisciplinary professionals delivering restorative solutions to structural heart disease patients. Anteris’ lead product, the DurAVR® THV, was designed in collaboration with the world’s leading interventional cardiologists and cardiac surgeons to treat aortic stenosis – a potentially life-threatening condition resulting from the narrowing of the aortic valve. The balloon-expandable DurAVR® THV is the first biomimetic valve, which is shaped to mimic the performance of a healthy human aortic valve and aims to replicate normal aortic blood flow. DurAVR® THV is made using a single piece of molded ADAPT® tissue, Anteris’ patented anti-calcification tissue technology. ADAPT® tissue, which is FDA-cleared, has been used clinically for over 10 years and distributed for use in over 55,000 patients worldwide. The DurAVR® THV System is comprised of the DurAVR® valve, the ADAPT® tissue, and the balloon-expandable ComASUR® Delivery System. Forward-Looking Statements This announcement contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. Forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “budget,” “target,” “aim,” “strategy,” “plan,” “guidance,” “outlook,” “may,” “should,” “could,” “will,” “would,” “will be,” “will continue,” “will likely result” and similar expressions, although not all forward-looking statements contain these identifying words. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions, including those described under “Risk Factors” in Anteris’ Annual Report on Form 10-K for the fiscal period ended December 31, 2025 that was filed with the Securities and Exchange Commission and ASX. Readers are cautioned not to put undue reliance on forward-looking statements, and except as required by law, Anteris does not assume any obligation to update any of these forward-looking statements to conform these statements to actual results or revised expectations. For more information: Global Investor Relationsinvestors@anteristech.comDebbie OrmsbyAnteris Technologies Global Corp.+61 1300 550 310 | +61 7 3152 3200Investor Relations (US)mchatterjee@bplifescience.comMalini Chatterjee, Ph.D.Blueprint Life Science Group+1 917 330 4269 Websitewww.anteristech.com X@AnterisTech LinkedInhttps://www.linkedin.com/company/anteristech
Parasol Med Tech Secures $2.75M to Improve Stroke Prevention in Atrial Fibrillation
Parasol Med Tech, a Chicago-based medical device company, today announced that it has closed an oversubscribed $2.75 million pre-seed funding round. The round included participation from Harper Court Ventures, UChicago Medicine Ventures, a venture investment vehicle of the University of Chicago Medical Center, and Cardiovascular Innovation Ventures, the venture arm […]
Biograph Completes First U.S. Study with Caristo Diagnostics’ AI-Powered Coronary Inflammation Detection, Finding Risk in Over 42% of Asymptomatic Patients
SAN MATEO, Calif. & NEW YORK–(BUSINESS WIRE)–Biograph study shows AI imaging detected coronary inflammation in 43% of asymptomatic adults, which standard blood tests failed to identify.
Orchestra BioMed to Host R&D Day Featuring Clinical Insights and Development Plans for AVIM Therapy and Virtue® SAB
Company leadership, leading cardiologists and trial investigators to discuss unmet patient needs, BACKBEAT and Virtue pivotal trials, and upcoming milestones; in person in New York City and via live webcastNEW HOPE, Pa., Oct. 22, 2026 (GLOBE NEWSWIRE) — Orchestra BioMed Holdings, Inc. (Nasdaq: OBIO, “Orchestra BioMed” or the “Company”), a biomedical company accelerating high-impact technologies to patients through risk-reward sharing partnerships, today announced it will host an R&D Day on November 12th, 2026, at 3:00pm ET in New York City. The event will also be available via live webcast. Orchestra BioMed leadership will be joined by key leading cardiologists to discuss the clinical and treatment burden associated with uncontrolled hypertension in pacemaker-indicated patients and restenosis in coronary stent interventions, as well as the potential for AVIM Therapy and Virtue SAB to address these unmet needs. The program will also highlight key upcoming clinical milestones and explore the commercial potential of AVIM Therapy and Virtue SAB. R&D Day Agenda 3:00 PM | Opening Remarks Led by David Hochman, Chairman and Chief Executive Officer 3:10 PM | AVIM Therapy, BACKBEAT Pivotal Trial & Medtronic Strategic CollaborationLed by David Hochman & Avi Fischer, MD, Senior Vice President, Medical Affairs & Innovation Physician Speakers: Vivek Reddy, MD, Executive Chairman of the BACKBEAT Trial Steering Committee, Director of Cardiac Arrhythmia Services, Mount Sinai Hospital and the Mount Sinai Health SystemMarat Fudim, MD, Associate Professor of Cardiology, Advanced Heart Failure, Duke University Medical Center 4:20 PM | Virtue SAB & Virtue Pivotal Trial Led by Darren Sherman, President & Chief Operating OfficerPhysician Speakers: Dean Kereiakes, MD, Virtue Trial Co-PI, Chairman of The Christ Hospital Heart and Vascular Institute, The Christ Hospital Health NetworkAllen Jeremias, MD, Virtue Trial Co-PI, Director of the Cardiac Catheterization Laboratory at St. Francis Hospital & Heart Center, New York and an Executive Director for Optimizing PCI 5:15 PM | Q&A Closing Remarks Moderated by David Hochman and Darren Sherman Registration and Webcast Information The R&D Day will be held in person in New York City and streamed via live webcast, and available for replay following the event. In-person attendance: Please register here. Space is limited, and the Company may not be able to accommodate all requests. In-person registrations are subject to written confirmation, and venue and event details will be provided upon confirmation.Live webcast: Please register here to access the live webcast. A replay will be available on the Investors section of Orchestra BioMed’s website following the event. About Orchestra BioMed Orchestra BioMed is a biomedical innovation company accelerating high-impact technologies to patients through strategic collaborations with market-leading global medical device companies. The Company’s two flagship product candidates – Atrioventricular Interval Modulation (AVIM) Therapy and Virtue® Sirolimus AngioInfusion™ Balloon (Virtue SAB) – are currently undergoing pivotal clinical trials for their lead indications, each representing multi-billion-dollar annual global market opportunities. The BACKBEAT Global Pivotal Trial evaluating AVIM Therapy has completed enrollment. AVIM Therapy is a bioelectronic treatment for hypertension, the leading risk factor for death worldwide, and is designed to be delivered by a pacemaker and achieve immediate, substantial and sustained reductions in blood pressure in patients with hypertensive heart disease. The Company has a strategic collaboration with Medtronic (NYSE: MDT), one of the largest medical device companies in the world and the global leader in cardiac pacing therapies, for the development and commercialization of AVIM Therapy for the treatment of uncontrolled hypertension in pacemaker-indicated patients. AVIM Therapy has two FDA Breakthrough Device Designations. Virtue SAB is a first-of-its-kind, non-coated drug delivery Angioinfusion balloon system designed to infuse a large liquid dose of proprietary extended-release formulation of sirolimus, SirolimusEFR™, for the treatment of atherosclerotic artery disease, the leading cause of mortality worldwide. Virtue SAB has been granted Breakthrough Device Designation by the FDA for the treatment of coronary in-stent restenosis, coronary small vessel disease and below-the-knee peripheral artery disease. The Virtue Pivotal Trial evaluating Virtue SAB for the treatment of coronary in-stent restenosis is currently enrolling patients. For further information about Orchestra BioMed, please visit www.orchestrabiomed.com, and follow us on LinkedIn. Investor Contact:Silas NewcombOrchestra BioMedsnewcomb@orchestrabiomed.com Media Contact:Nina PremuticoOrchestra BioMednpremutico@orchestrabiomed.com
Teleflex Announces FDA Breakthrough Device Designation for Freesolve™ Resorbable Magnesium Scaffold
WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation (BDD) for its Freesolve™ Resorbable Magnesium Scaffold (RMS) for percutaneous coronary intervention (PCI). To qualify for a BDD, device technology must address an unmet clinical need and show that it has the potential to provide for more effective treatment of life-threateni
FDA Approval of Edwards Lifesciences’ PASCAL Precision System Opens New Treatment Pathway for Patients With Tricuspid Valve Disease
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences Corporation (NYSE: EW) today announced that the U.S. Food and Drug Administration (FDA) has approved its PASCAL Precision system for tricuspid valve repair. The system is indicated for improving quality of life and functional status in patients with symptomatic severe tricuspid regurgitation (TR) despite optimal medical […]
egnite 2026 Benchmark Report: Four-Class GDMT Prescribing in Systolic Heart Failure More Than Doubles, Yet Four in Five Patients Are Not Prescribed Full Guideline Therapy
Real-world data from 47 U.S. health systems shows three-year survival of 76% among systolic heart failure patients prescribed four GDMT classes, versus 52% among those prescribed none ALISO VIEJO, Calif., Oct. 21, 2026 /PRNewswire/ — egnite, Inc., a technology company advancing…
Elucid Announces FDA Clearance of FFR-IQ™ and Commercial Availability of the Most Accurate¹ FFR-CT Software
BOSTON–(BUSINESS WIRE)– #510k–Elucid has received FDA 510(k) clearance of FFR-IQ™, its software for noninvasive estimation of fractional flow reserve from coronary CT angiography.



