The Latest Cardiac and Vascular News
BIRMINGHAM, Ala. — January 8, 2025 — Rampart, a Birmingham, Alabama–based medical device company redefining interventional radiation safety, today announced the launch of the SECURE Clinical Program, Studies Evaluating Clinical Utility of Radiation mitigation Equipment, a first-of-its-kind, multi-specialty clinical initiative designed to further advance the scientific evidence for next-generation radiation […]
Agreement expands Cardio Diagnostics’ global footprint and supports improved detection and management of coronary heart disease in India. CHICAGO–(BUSINESS WIRE)–Cardio Diagnostics Holdings, Inc. (NASDAQ: CDIO), a leader in epigenetics and AI-driven Precision Cardiovascular Medicine, Aimil Ltd., a company at the forefront of the instrumentation industry in India since 1932, introducing innovative, best-in-class […]
SS Innovations Develops New Instruments to Advance Robotic Surgery in Large, Underserved Patient Segments, including Pediatric and Cardiac Markets
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
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
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.
Sonico-CX provides a safe and effective option for treating calcified coronary lesions. SINGAPORE, Jan. 6, 2026 /PRNewswire/ — Spectrumedics Medical (hereinafter “Spectrumedics”) is pleased to announce that its Sonico-CX Intravascular Lithotripsy (IVL) System has obtained CE Mark…
With over 80 issued patents and 39 pending patent applications, Autonomix is building a comprehensive, global IP portfolio in nerve-sensing and modulation Newly granted patent further strengthens the Company’s strategic position in a multi-billion-dollar market opportunity, unlocking potential across cardiovascular, renal, and other high-burden diseases THE WOODLANDS, TX, Dec. 30, 2025 (GLOBE NEWSWIRE) — Autonomix Medical, Inc. (NASDAQ: AMIX) (“Autonomix” or the “Company”), a medical device company dedicated to advancing precision nerve-targeted treatments, today announced the European Patent Office (EPO) has granted Patent No. EP4230133 (the ‘133 patent), titled, “Controlled and Precise Treatment of Cardiac Tissues.” The newly granted ‘133 patent covers systems, devices, and methods that sense autonomic/cardiac signals, map targets, and then deliver therapy with closed-loop feedback to precisely treat cardiac tissues by performing feedback-driven neuromodulation, denervation, and/or ablation of tissues. “This European patent represents another important milestone in strengthening and expanding the global IP foundation behind our breakthrough technology platform, commented Brad Hauser, CEO of Autonomix. This patent builds on and broadens the protection provided by our recently issued U.S. Patent No. 12,369,852, further enhancing our ability to provide precision nerve-targeted therapies that have the potential to transform treatment in key, high-growth areas of cardiology, including renal denervation for hypertension, arrhythmia management, heart failure, and refractory angina, while reducing complications.” In particular, the ‘133 patent relates to systems, devices, and methods for performing precise treatment, mapping, and/or testing of tissues and for identifying, localizing, monitoring, and mapping neural traffic near targeted regions. Further, the patent highlights applications across arrhythmias (atrial & ventricular), ischemia/angina (including refractory angina pain), coronary spasm, myocardial infarction risk modulation, heart failure, hypertension (including interplay with renal-cardiac nerves), and plaque/inflammation modulation, where local, feedback-guided denervation or modulation may reduce dependence on systemic beta blockade and its side effects. Autonomix’s first-in-class technology constitutes a platform with the potential to address dozens of indications in multiple high-need therapeutic areas, including cardiology and resistant hypertension or high blood pressure, interventional pain management, pulmonary and gastrointestinal disorders, and more. For more information about the Company’s technology, please visit autonomix.com. About Autonomix Medical, Inc. Autonomix is a medical device company focused on advancing innovative technologies to revolutionize how diseases involving the nervous system are diagnosed and treated. The Company’s first-in-class platform system technology includes a catheter-based microchip sensing array that may have the ability to detect and differentiate neural signals with greater sensitivity than currently available technologies. We believe this will enable, for the first time ever, transvascular diagnosis and treatment of diseases involving the peripheral nervous system virtually anywhere in the body. We are initially developing this technology for the treatment of pain, with initial trials focused on pancreatic cancer, a condition that causes debilitating pain and is without a reliable solution. Our technology constitutes a platform to address dozens of potential indications, including cardiology, hypertension and chronic pain management, across a wide disease spectrum. Our technology is investigational and has not yet been cleared for marketing in the United States. For more information, visit autonomix.com and connect with the Company on X, LinkedIn, Instagram and Facebook. Forward Looking Statements Some of the statements in this release are “forward-looking statements,” which involve risks and uncertainties. Such forward-looking statements can be identified by the use of words such as “should,” “might,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” and “proposes.” Although Autonomix believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. You are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” and elsewhere in the Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on May 29, 2025, and from time to time, our other filings with the SEC. Forward-looking statements speak only as of the date of this press release and Autonomix does not undertake any duty to update any forward-looking statements except as may be required by law. Investor and Media Contact JTC Team, LLCJenene Thomas908.824.0775autonomix@jtcir.com
IRVINE, Calif.–(BUSINESS WIRE)–Edwards Lifesciences (NYSE: EW) today announced the company’s SAPIEN M3 mitral valve replacement system is the first transcatheter therapy utilizing a transseptal approach to receive U.S. Food and Drug Administration (FDA) approval for the treatment of mitral regurgitation (MR). The SAPIEN M3 transcatheter mitral valve replacement (TMVR) system […]
Reinforces Role of AI-Powered Quantitative Coronary Plaque AssessmentMOUNTAIN VIEW, Calif., Dec. 18, 2025 (GLOBE NEWSWIRE) — Heartflow, Inc. (Heartflow) (Nasdaq: HTFL), the leader in AI technology for coronary artery disease (CAD), announced the American College of Cardiology (ACC) and the American Heart Association (AHA) published new scientific statements supporting the prognostic value of quantifying coronary plaque and reinforcing the critical role of the coronary computed tomography angiography (CTA) + Heartflow pathway in CAD patient management. The ACC’s consensus recommendations, published this week in JACC: Cardiovascular Imaging, highlight the importance of quantitative plaque assessment and underscore the benefits of adopting AI-powered Heartflow Plaque Analysis for personalized, precision cardiac care.1 The ACC statement elevates plaque analysis from an emerging technology to a defined clinical consideration in CAD management, outlining appropriate patient selection and best practices for interpreting and reporting. In direct alignment with the ACC’s call for rigorous quality assurance, reproducible results, and “human in the loop” analysis, Heartflow delivers a differentiated standard for clinical plaque quantification by combining AI-driven analysis with expert quality review. 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.2 This rigor, together with Heartflow’s commitment to standardized reporting and advanced algorithmic approaches such as adaptive thresholds, reflects a level of validation and quality oversight consistent with ACC guidance. The AHA statement, published recently in Circulation, reinforces plaque burden and composition as central in managing nonobstructive CAD.3 The expert authors emphasize that patients with nonobstructive CAD should not be considered low-risk, recognizing that coronary plaque burden, extent, and composition are major determinants of outcomes. Earlier this year, a commission perspective published in The Lancet called for a fundamental shift in managing CAD, urging clinicians to focus on identifying and managing plaque early, before the opportunity for prevention has been lost.4 Together, the scientific statements from ACC and AHA reinforce that broader paradigm shift toward understanding plaque burden, not just artery obstruction, in modern CAD management. “The ACC and AHA scientific statements address an important need by providing evidence-based consensus recommendations for clinicians and imagers, solidifying coronary CTA-based quantitative plaque analysis as a powerful tool for enhanced risk stratification in patients with suspected CAD,” said Ron Blankstein, M.D., writing committee member for both the ACC and AHA statements, Director of Cardiac Computed Tomography at Brigham and Women’s Hospital, and Professor of Medicine and Radiology at Harvard Medical School. “These statements highlight the limitations of current methods to assess risk based on risk factors or stenosis severity alone. Integrating AI-powered technology into clinical practice using ACC and AHA’s guidance can help clinicians move beyond diagnosing blockages, toward predicting and preventing major cardiovascular events.” Both the ACC and AHA scientific statements support the use of quantitative coronary plaque analysis to identify high-risk patients, enabling the immediate and appropriate initiation of preventive treatment. Heartflow Plaque Analysis addresses the need to quantify disease following visual detection of plaque, and is delivered instantly upon order to maintain seamless clinical integration and enable timely clinical decision-making. “The ACC and AHA scientific statements signal growing consensus that plaque assessment is essential for risk stratification, prevention, and long-term CAD management. Heartflow Plaque Analysis enables more precise risk stratification for personalized, preventive treatment plans,” said Campbell Rogers, M.D., F.A.C.C., Chief Medical Officer at Heartflow. “The expert guidance articulates the need for rigorous validation and standardization, which Heartflow is uniquely positioned to address, given our technology and quality systems already align with these stringent recommendations. We are energized by the opportunity to continue collaborating with clinicians as a catalyst to redefine and improve precision cardiovascular care.” The ACC and AHA’s scientific statements reflect a growing body of clinical evidence further substantiating the prognostic significance of Heartflow Plaque Analysis. 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.5 The company is generating additional real-world evidence through the DECIDE registry, 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 Plaque Analysis with Plaque Staging* was added compared to their management based on CCTA alone.6 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. Key benefits include: Proprietary data pipeline: Built from more than 110 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 ContactElliot Levyelevy@heartflow.com Investor ContactNick Laudiconlaudico@heartflow.com 1 Chandrashekhar Y, Blankstein R, Shaw L. et al. Quantitative Coronary Plaque Analysis in Clinical Practice: 2025 ACC Scientific Statement: A Report of the American College of Cardiology. J Am Coll Cardiol Img. doi: 10.1016/j.jcmg.2025.11.0082 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.3 Slipczuk L, Blankstein R, Bucciarelli-Ducci C. et al. State of the art: evaluation and medical management of nonobstructive coronary artery disease in patients with chest pain: a scientific statement from the American Heart Association. Circulation. 2025;152:e443–e466. doi: 10.1161/CIR.00000000000013944 Zaman, Sarah et al. The Lancet Commission on rethinking coronary artery disease: moving from ischaemia to atheroma. The Lancet. 2025;405,10486:1264-1312. Doi: 10.1016/S0140-6736(25)00055-85 Fairbairn et al. AHA 2025.6 DECIDE Registry. Rinehart, et al., presented at SCCT 2025.*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.
