Author: Ken Dropiewski

Precision Redefined: LUMA Vision Completes VERAFEYE™ 4D-Guided Persistent AF Ablations, Demonstrating a Significant Advancement in Simplifying Image-Guided Cardiac Care

DUBLIN, Jan. 7, 2026 /PRNewswire/ — LUMA Vision Ltd., a leader in cardiac 4D navigation and imaging, today announced the successful completion of 15 VERAFEYE™-guided persistent atrial fibrillation (AF) ablation procedures conducted as part of a clinical study in collaboration with…

W. L. GORE & ASSOCIATES TO ACQUIRE CONFORMAL MEDICAL, EXPANDING ITS PRESENCE IN ENDOVASCULAR TREATMENTS

Acquisition adds next-generation CLAAS® AcuFORM™ Technology to Gore’s portfolio CAUTION: Investigational Device. Limited by federal (or United States) law to investigational use. Outside the United States, the device is intended exclusively for clinical investigation. Not approved for commercial use. NEWARK, Del., Jan. 5, 2026 /PRNewswire/ — W. L. Gore & Associates, Inc. (Gore) […]

CVRx Announces Implementation of New Category I CPT Codes for Barostim Therapy

MINNEAPOLIS, Jan. 06, 2026 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, confirmed today that Category I Current Procedural Terminology (CPT) codes for baroreflex activation therapy using its Barostim device replaced the Category III codes as of Jan. 1, 2026. In the U.S. healthcare system, Category I CPT codes signify established procedures, supporting adoption, coverage, and reimbursement nationwide. The new CPT codes for use with Barostim procedures are available in the reimbursement guide here, and on CVRx’s website. U.S. hospitals and physicians performing Barostim procedures should update their billing systems and start using these new codes for all procedures performed on or after Jan. 1, 2026. “We believe the new Category I CPT codes will enable more predictable and consistent reimbursement for Barostim patients and healthcare professionals,” said Kevin Hykes, President and Chief Executive Officer of CVRx, “and validate the important role of Barostim therapy in the heart failure treatment continuum.” About CVRx, Inc.CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has been certified as compliant with the EU Medical Device Regulation (MDR) and holds CE Mark approval for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. The statements regarding the anticipated effect the new codes will have on Barostim’s adoption are forward-looking statements. These statements speak only as of the date of this press release and are based on our current expectations and projections about the future and are subject to a number of known and unknown risks, uncertainties and assumptions that could cause actual results to differ from our expectations, including the actual impact the new codes have on reimbursement and patient access. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. Investor Contact:Mark Klausner or Mike VallieICR Healthcare443-213-0501ir@cvrx.com Media Contact:Emily MeyersCVRx, Inc.763-416-2853emeyers@cvrx.com

Heartflow Plaque Analysis Now Covered by Aetna Insurance Plans Nationwide and for the Majority of Insured Lives in the U.S.

Fourth major national payer releases positive comprehensive coverage for AI-powered Heartflow Plaque AnalysisMOUNTAIN VIEW, Calif., Jan. 06, 2026 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), today announced Heartflow Plaque Analysis is now covered by Aetna across all lines of business, including Commercial, Medicare Advantage, and Aetna Better Health Medicaid plans. Aetna is the fourth major national commercial insurer to update its policies to cover Heartflow Plaque Analysis to fully align with the guidelines issued by radiology benefit manager EviCore, following similar decisions by Humana, Cigna, and UnitedHealthcare. Heartflow Plaque Analysis is covered for the majority of insured lives across the United States. This coverage milestone follows the American Medical Association’s recent implementation of the new Category I Current Procedural Terminology (CPT®) payment code 75577 for Heartflow Plaque Analysis, effective January 1, 2026, which established 0.85 relative value units (RVUs) and a combined total of 4.00 RVUs for physicians performing the service. “Aetna’s decision to cover Heartflow Plaque Analysis nationwide is a pivotal step in expanding access to our AI-driven plaque quantification and characterization technology,” said John Farquhar, President and CEO of Heartflow. “With four major commercial payers and Medicare now recognizing the innovation and value of our platform, more clinicians can gain earlier, clearer insights into coronary plaque. More patients will benefit from early detection and precise quantification of plaque with Heartflow Plaque Analysis, leading to more personalized treatment strategies and improved prognostic assessment, helping set a new benchmark for cardiovascular care.” The updated coverage became effective on December 23, 2025 for Aetna patients with acute or stable chest pain and mild-to-moderate narrowing of coronary arteries (1-69% stenosis) identified on coronary CTA. The policy expands access for patients to AI-driven plaque analysis, supporting earlier diagnosis, personalized risk stratification, and more precise management of CAD. The new CPT code was issued in response to increased utilization of AI-powered plaque quantification and characterization technology like Heartflow Plaque Analysis and strong clinical evidence supporting its value. Together, broader national payer coverage and Category I reimbursement position the Heartflow platform as the highest-value pathway in cardiac CT, expanding access and supporting practical adoption in clinical practice. Heartflow’s continued advancement of Heartflow Plaque Analysis builds on the real-world evidence demonstrated in the landmark DECIDE Registry data, the largest prospective registry evaluating the clinical impact of Heartflow Plaque Analysis on medical management decisions. The DECIDE registry showed that more than 50% of patients had their medical management changed when Heartflow Plaque Analysis with Heartflow Plaque Staging* was added compared to their management based on CCTA alone.1 A retrospective analysis of symptomatic patients from a cohort of the FISH&CHIPS Study presented at the AHA Scientific Sessions 2025 provided the largest validation to date of the Heartflow Plaque Staging framework based on total plaque volume measurement as a predictor of future heart attacks or cardiovascular death.2 Heartflow Plaque Analysis is the only FDA-cleared, AI-powered plaque quantification tool with 95% agreement to the gold standard, IVUS, using blinded core lab adjudication.3 About Heartflow’s Technology and ResearchHeartflow’s technology is redefining precision cardiovascular care through clinically-proven AI and the world’s largest coronary imaging dataset. Heartflow has been adopted by more than 1,400 institutions globally and continues to strengthen its commercial presence to make this cutting-edge solution more widely available to an increasingly diverse patient population. Backed by ACC/AHA guidelines and supported by more than 600 peer-reviewed publications, Heartflow has redefined how clinicians manage care for over 500,000 patients worldwide.4 Key benefits include: Proprietary data pipeline: Built from more than 160 million annotated CTA images, Heartflow’s data foundation powers advanced AI models that deliver highly accurate, reproducible insights across diverse patient populations.Extensive clinical and real-world validation: Heartflow’s AI-driven solutions have been validated through clinical evidence in over 100 studies assessing over 365,000 patients. Proven in real-world practice with reproducibility and accuracy, Heartflow’s coronary CTA image acceptance rates exceed 97%.Seamless clinical integration via upgraded workflow: Heartflow delivers final quality-reviewed analyses instantly upon order, enabling clinicians to move from diagnosis to decision without delay.Quality system, global security and patient-data integrity compliance: Heartflow meets or exceeds leading international standards, including HITRUST, SOC 2 Type 2, ISO 13485, and ISO 27001. About Heartflow, Inc.Heartflow is transforming coronary artery disease from the world’s leading cause of death into a condition that can be detected early, diagnosed accurately, and managed for life. The Heartflow One platform uses AI to turn coronary CTA images into personalized 3D models of the heart, providing clinically meaningful, actionable insights into plaque location, volume, and composition and its effect on blood flow — all without invasive procedures. Discover how we’re shaping the future of cardiovascular care at heartflow.com. Media Contact Elliot Levy elevy@heartflow.com Investor Contact Nick Laudico nlaudico@heartflow.com 1 DECIDE Registry. Rinehart, et al., presented at SCCT 2025.2 Fairbairn et al., presented at AHA 2025.3 Ihdayhid A, et al. Radiol Cardiothorac Imaging. 2024. doi: 10.1148/ryct.230312 and internal bridging study with ICC correlation between first generation and second generation Plaque Analysis algorithm.4 Gulati, et al. 2021 AHA/ACC/ASE/CHEST/SAEM/SCCT/SCMR Guideline for the Evaluation & Diagnosis of Chest Pain. J Am Coll Cardiol.*Heartflow Plaque Analysis is an FDA-cleared device. Heartflow Plaque Staging is an investigational-only framework, and its safety and effectiveness have not been reviewed by the FDA.

Milestone Pharmaceuticals Announces Acceptance of Marketing Authorization Application for Etripamil Nasal Spray in PSVT by the European Medicines Agency

 European decision on approval is expected by Q1 2027If approved, etripamil nasal spray is expected to offer patients a safe and effective self-administered treatment option for PSVT outside of the healthcare setting MONTREAL and CHARLOTTE, N.C., Jan. 06, 2026 (GLOBE NEWSWIRE) — Milestone® Pharmaceuticals Inc. (Nasdaq: MIST), a biopharmaceutical company focused on the development and commercialization of innovative cardiovascular medicines, today announced the acceptance of a Marketing Authorization Application (MAA) by the European Medicines Agency (EMA) seeking the approval of etripamil nasal spray, developed to be the first rapid, reliable option in the treatment of paroxysmal supraventricular tachycardia (PSVT) outside of the healthcare setting. Etripamil, which has the conditionally approved brand name TACHYMIST™ in Europe, is an investigational, novel calcium channel blocker delivered via a nasal spray by the patient for the potential treatment of PSVT and other cardiac arrhythmias. A decision on approval is expected by the first quarter of 2027. “Following guidance from the EMA, this MAA incorporates the global clinical data package that supported the U.S. Food and Drug Administration approval of etripamil for the treatment of PSVT,” said Joseph Oliveto, President and Chief Executive Officer of Milestone Pharmaceuticals. “TACHYMIST could become the first approved patient self-administered therapy representing a meaningful step forward in patient care for the approximately two million people suffering from PSVT in Europe.” About the Pivotal RAPID Phase 3 TrialThe MAA submission is supported by efficacy, safety, and tolerability results from a robust clinical trial program based on data from more than 1,800 participants and more than 2,000 episodes of PSVT. This includes the successful Phase 3 RAPID trial, a global, randomized, double-blind comparison of etripamil vs. placebo, published in The Lancet in 2023. In clinical studies, participants using etripamil were two times more likely to convert symptomatic PSVT to sinus rhythm and did so more than three times faster compared with placebo. The RAPID trial achieved its primary endpoint with 64% of those who self-administered etripamil (N=99) converting from PSVT to sinus rhythm within 30 minutes compared to 31% on placebo (N=85) (HR=2.62; p