SS Innovations Develops New Instruments to Advance Robotic Surgery in Large, Underserved Patient Segments, including Pediatric and Cardiac Markets
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Stereotaxis Receives FDA Approval for MAGiC Ablation Catheter
ST. LOUIS, Jan. 06, 2026 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained U.S. Food and Drug Administration (FDA) approval for the MAGiC™ Magnetic Interventional Ablation Catheter.
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
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.
GORE GAINS FDA APPROVAL FOR FIRST DEEP VENOUS STENT INDICATED FOR THE IVC AND ILIOFEMORAL VEINS
The GORE® VIABAHN® FORTEGRA Venous Stent is engineered to offer an optimal balance of conformability and compression resistance for treating a broad range of patients. FLAGSTAFF, Ariz., Jan. 6, 2026 /PRNewswire/ — W. L. Gore & Associates’ medical business (Gore) has announced the FDA…
Spectrumedics Announces CE Mark Approval For Its Coronary Intravascular Lithotripsy System
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…
Ceribell Receives FDA Breakthrough Device Designation for LVO Stroke Detection and Monitoring Solution
Clearance would position the Ceribell System as the first and only point-of-care electroencephalography (EEG) technology to aid in detection and monitoring of Large Vessel Occlusion (LVO) stroke in the hospital setting Clearance would position the Ceribell System as the first and only point-of-care electroencephalography (EEG) technology to aid in detection and monitoring of Large Vessel Occlusion (LVO) stroke in the hospital setting
Autonomix Medical, Inc. Granted European Patent on Platform Technology Enabling Precision Nerve-Targeted Therapies in Cardiology
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
Conavi Medical Reports Fiscal Year 2025 Results and Operational Highlights
TORONTO, Dec. 29, 2025 (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 reported financial results and provided an operational update for the fiscal year ended September 30, 2025.



