The Latest Cardiac and Vascular News
MADRID, April 17, 2026 /PRNewswire/ — Corify Care today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for the ACORYS® System, the first imageless, non-invasive cardiac mapping platform capable of delivering a global, four-chamber view of cardiac…
NEW YORK–(BUSINESS WIRE)– #BetterOutcomes–AccurKardia, an ECG analytics software company focused on establishing ECG as a broad biomarker, today announced a multi-year agreement with Specialized Medical. Under this partnership, AccurKardia’s FDA-cleared Class II software as a medical device (SaMD), AccurECG™ 2.0, is actively powering Specialized Medical’s state-of-the-art cardiac monitoring operations, which currently serve more than 20 clinics, medical practices, and hospitals across four states. Specialized
Now CE Marked, the Kardia 12L ECG System leverages AI to detect 35 cardiac determinations, simplifying the ECG process and expediting access to critical heart data
AliveCor’s Kardia 12L launches in Europe
AliveCor Launches AI-Powered Kardia 12L in Europe: The World’s First Handheld 12-Lead ECG with a Unique Single-Cable Design
MOUNTAIN VIEW, Calif., April 15, 2026 (GLOBE NEWSWIRE) — AliveCor, the global leader in AI-powered cardiology, today announced it has received CE Mark (Conformité Européenne) for the Kardia™ 12L electrocardiogram (ECG) System powered by KAI™ 12L AI technology. Kardia 12L is the world’s first AI-powered, portable 12-lead ECG system featuring a unique, single-cable design for Health Care Professionals (HCPs). Powered by KAI 12L, the system enables faster, easier detection of 35 cardiac determinations, including acute myocardial infarction (MI) and the most common types of cardiac ischemia. “Securing CE Mark for the Kardia 12L is a defining moment in our strategy to scale AliveCor’s global footprint,” said Simona Esposito, Senior Vice President of Sales, Global Markets at AliveCor. “Our priority is to get this life-saving technology into the hands of as many clinicians as possible, especially in settings where traditional, bulky ECG carts simply aren’t practical. By simplifying the hardware without sacrificing diagnostic depth, we are fundamentally improving access to high-quality cardiac care and reducing the burden of cardiovascular disease in the EU.” Technical Specifications and Capabilities of Kardia 12LKardia 12L is the portable, AI-guided, 12-lead ECG solution whose measurements and ECG interpretation are highly similar to standard 12-lead ECG solutions, right at the point of care, enabling rapid acquisition of complete ECG information and offering a better patient experience. 35 Cardiac Determinations: KAI 12L is the first AI of its kind to detect life-threatening cardiac conditions using a reduced leadset and can identify a comprehensive range of conditions. This includes 14 arrhythmias and 21 morphologies including serious conditions like acute MI and the most common types of cardiac ischemia.Rapid Detection: Specifically designed to expand access to accurate cardiac data across diverse healthcare and acute settings, the system allows for the rapid identification of life-threatening conditions like heart attack.Operational Efficiency: The device weighs just 0.13 kg (0.3 lbs) and is battery-operated, allowing it to be used by HCPs in primary care, urgent care, pharmacy, the home and rural clinics where traditional ECG machines may be impractical due to their size and complexity.Improved Patient and Clinician Experience: The simplified five-electrode setup makes it less invasive for patients, who do not need to fully disrobe during a reading, and typically allows for faster acquisition. Research has shown nearly a 30% reduction in ECG acquisition time compared to standard 12-lead setups. “In a fast-paced clinical environment, every second counts, but we cannot sacrifice accuracy for speed,” said Dr. Alejandro Barbagelata, Adjunct Assistant Professor of Medicine and Cardiology at Duke University. “Kardia 12L offers a unique combination of portability and diagnostic depth, allowing HCPs to make informed care decisions. By streamlining the acquisition process, it enables clinicians to identify life-threatening conditions like MI much faster, leading to better patient outcomes across the board.” Since its FDA clearance and subsequent launch in the United States in June 2024, Kardia 12L has seen growing global adoption including in India, Australia, New Zealand, Vietnam and Canada. The system has been adopted by clinicians across the globe capturing critical heart data on tens of thousands of patients. Most notably, the system has identified over 4,000 instances of MI and ischemia, facilitating life-saving care for those who need it most. This launch comes at a pivotal time, as the European Union reinforces its commitment to tackling cardiovascular diseases–the leading cause of mortality in Europe–through its EU Cardiovascular Health Plan, which prioritizes early detection, prevention, and improved access to care. Kardia 12L will be first available for healthcare providers in France, Germany, Italy, Spain, and the United Kingdom, and will be followed by additional European countries soon. For more information, please visit: https://alivecor.com/uk/products/kardia12l. Frequently Asked Questions Where is the Kardia 12L ECG System available in Europe? The Kardia 12L ECG System will be first available for healthcare providers in France, Germany, Italy, Spain, and the United Kingdom, followed by additional European countries soon. This follows the recent receipt of the CE Mark, allowing for its distribution across the European Economic Area. How does Kardia 12L compare to traditional ECG carts? Unlike traditional ECG carts that require 10 leads and bulky hardware, the Kardia 12L uses a unique single-cable, five-electrode design. It is pocket-sized, battery-operated, and uses AI to detect 35 cardiac determinations, making it significantly more portable and faster to deploy in a variety of healthcare facilities and acute settings, including primary and urgent care offices, mobile clinics, in pharmacies, by HCPs in home visits and other underserved or rural venues. How many and what cardiac conditions can the Kardia 12L detect? Powered by KAI 12L AI, the system is cleared to detect 35 cardiac determinations, including 14 arrhythmias (such as Atrial Fibrillation and Atrial Bigeminy) and 21 morphologies. Does the Kardia 12L require specialized training for clinicians? No. The device requires minimal self-guided training. Its simplified five-electrode placement is more intuitive than standard 10-lead setups, which can reduce the risk of lead reversal and shorten the time required for patient preparation. Is the Kardia 12L ECG System intended for home use? The Kardia 12L is intended for use by healthcare professionals in clinical environments including hospitals, urgent care centers, primary care practices, rural clinics, and pharmacy and home visits by an HCP. About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) devices, is transforming cardiology with its medical-grade AI solutions. The company was named to the inaugural TIME World’s Top Health Tech Companies 2025 list – recognition of its commitment to delivering innovative devices and services that empower patients and physicians with personalized, actionable heart data. With over 350 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. The company’s latest offering, Kardia 12L ECG System, powered by KAI 12L cleared to detect 39 cardiac conditions (with determination availability varying by geography), was designed exclusively for use by healthcare providers. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook. Media ContactMorgan Mathis Director of Corporate Communications, AliveCor press@alivecor.com Sales Contact OUSenquiries@alivecor.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/d510c9dc-7eb1-45bd-ba22-aa01f14d3e40
Clinical Evidence Further Demonstrates Efficacy and Accuracy of VIVO for Ventricular ProceduresFORT MILL, S.C., April 13, 2026 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (NYSE American: VTAK) (“VTAK” or the “Company”) today announced that the results of a recently concluded VIVO study have been accepted in EP Europace, the leading European electrophysiology journal. The EP Europace journal provides an avenue of communication for top-quality European and international original, scientific work and reviews in the fields of arrhythmias, pacing and cellular electrophysiology. The journal offers readers a collection of contemporary, original, peer-reviewed papers, invited papers and editorial comments, together with book reviews and correspondence. The accepted manuscript titled “Accuracy of a non-invasive electrocardiographic imaging system in scar-dependent ventricular tachycardia: Relationship to arrhythmogenic substrate and imaging defined scar” highlights the feasibility of VIVO for scar-related ventricular tachycardia (VT) was led by Professor Tarv Dhanjal, MBChB(hons) PhD FRCP FESC FEHRA, Professor of Cardiology (University of Warwick). This study included 31 patients and mapped 48 VTs with VIVO and standard of care electroanatomical mapping systems to determine accuracy. The study concluded that ECGi mapping with VIVO can accurately predict the arrhythmogenic substrate for scar-dependent VT and incorporation of ECGi mapping to conventional VT ablation workflows may improve procedural efficiency. Of additional importance, this study compares VIVO’s predictability of epicardial VTs to a four step ECG based algorithm. In patients with Non-ischemic cardiomyopathy (NICM), the VIVO localization had a 100% specificity and 66.7% sensitivity, while a traditional four-step ECG-based algorithm had a sensitivity and specificity of 50% and 0%, further demonstrating VIVO’s capabilities to improve procedural workflow.David Jenkins, CEO of Catheter Precision, says, “This study demonstrates that VIVO works in a wide range of patients, including those with scar related ventricular tachycardia and that it can improve procedural workflow and reduce procedure time even in very difficult procedures like epicardial VT. We are very pleased with the outcomes of this study and plan to start a larger, multi-center study later this year to prove out these results on a larger scale.” About VIVO™ Catheter Precision’s VIVO (View Into Ventricular Onset), is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias pre-procedure, thereby streamlining workflow and reducing procedure time. VIVO has received marketing clearance from the U.S. FDA and has the CE Mark. About Catheter PrecisionCatheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “expect,” “anticipate,” “potential,” “will,” “may,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, expectations regarding potential strategic transactions, valuation outcomes, market opportunities, and the Company’s growth strategy. These statements involve risks and uncertainties that could cause actual results to differ materially. For a discussion of these risks, please refer to the Company’s filings with the SEC, including its most recent Forms 10-K and 10-Q. The Company undertakes no obligation to update any forward-looking statements. CONTACTS: Investor Relations973-691-2000IR@catheterprecision.com # # #
CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana announced US FDA clearance of its ECG-AI™ algorithm for cardiac amyloidosis.
LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM) (“Adagio” or “the Company”), a leading innovator in catheter ablation technologies for the treatment of cardiac arrhythmias, today announced that the U.S. Food and Drug Administration (FDA) has granted Investigational Device Exemption (IDE) approval to expand the Company’s FULCRUM-VT trial to evaluate the safety and effectiveness of the Company’s next-generation vCLAS Ultra-Low Temperature Ablation (ULTA) Ventri
Kardia 12L ECG System
Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac Conditions Using Reduced Leadset
MOUNTAIN VIEW, Calif., April 07, 2026 (GLOBE NEWSWIRE) — AliveCor, the global leader in AI-powered cardiology, today announced the regulatory registration of its Kardia™ 12L electrocardiogram (ECG) System powered by KAI™ 12L AI technology in Vietnam, marking an important step toward expanding AI-enabled cardiac diagnostics across Southeast Asia. The clearance supports Vietnam’s growing commitment to healthcare modernization and strengthens clinicians’ ability to detect and manage cardiovascular disease earlier and more efficiently. Cardiovascular disease remains a leading cause of death globally and across Asia, accounting for 33% of all deaths in Vietnam. Rising rates of hypertension, diabetes, and urbanization-related lifestyle changes are contributing to increasing cardiac risk. At the same time, the Ministry of Health has prioritized digital transformation, hospital capacity optimization, and expanded access to quality care, particularly beyond major urban centers. AI-enabled ECG systems like Kardia 12L align with broader efforts to advance care delivery, support data-driven decision-making, and extend specialist-level insight into frontline settings. Expanding Access to Hospital-Grade Cardiac Insight Kardia 12L is the portable, AI-powered, 12-lead ECG solution whose measurements and ECG interpretation are highly similar to standard 12-lead ECG solutions, right at the point of care, enabling rapid acquisition of complete ECG information and offering a better patient experience. By enabling fast, high-quality diagnostics in clinics, community health centers, and outpatient settings, the platform helps clinicians detect arrhythmias and morphologies including serious conditions like acute myocardial infarction and the most common types of cardiac ischemia earlier, without reliance on traditional, fixed hospital infrastructure. This capability is particularly relevant in Vietnam’s diverse healthcare landscape, where care is delivered across densely populated cities and remote and rural provinces. Kardia 12L supports a more distributed model of cardiac diagnostics, empowering healthcare professionals with accurate, actionable insights wherever patients are seen. Strengthening Healthcare Efficiency and Clinical Confidence Vietnam’s healthcare system continues to manage high patient volumes in major hospitals. Streamlined diagnostic workflows can play a meaningful role in reducing bottlenecks and improving throughput. Kardia 12L’s rapid acquisition and reduced electrode setup simplify the ECG process, shortening preparation time while maintaining diagnostic rigor. The simplified five-electrode setup makes it less invasive for patients, who do not need to fully disrobe during a reading, and typically allows for faster acquisition. Research has shown nearly a 30% reduction in ECG acquisition time compared to standard 12-lead setups. Faster acquisition enables healthcare professionals to move from suspicion to confirmation more quickly, thereby improving triage decisions and accelerating treatment pathways when needed. By combining portability with advanced AI interpretations, the system supports efficient clinician decision making while optimizing patient flow, contributing to both quality and efficiency. Enabling the Next Phase of Digital Cardiac Care As Vietnam advances national digital health initiatives, connected diagnostic tools are becoming increasingly important. Kardia 12L now strengthens AliveCor’s cardiovascular portfolio by standing alongside KardiaMobile and KardiaMobile 6L, creating a unified ecosystem for holistic management of the entire cardiovascular pathway. With its offering expansion into Vietnam, AliveCor reinforces its commitment to supporting healthcare professionals across Southeast Asia with scalable, technology-enabled cardiac solutions designed to improve early detection and expand access to quality cardiovascular care. For more information, sign up for exclusive updates on the Kardia 12L expansion outside of the U.S. here: https://alivecor.com/uk/forms/kardia-12l-interest-registration. About AliveCorAliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) devices, is transforming cardiology with its medical-grade AI solutions. The company was named to the inaugural TIME World’s Top Health Tech Companies 2025 list – recognition of its commitment to delivering innovative devices and services that empower patients and physicians with personalized, actionable heart data. With over 350 million ECGs recorded, the company’s Kardia devices are the most clinically validated personal ECGs in the world and can remotely detect six of the most common heart arrhythmias in just 30 seconds. The company’s latest offering, Kardia 12L ECG System, powered by KAI 12L cleared to detect 39 cardiac conditions (with determination availability varying by geography), was designed exclusively for use by healthcare providers. AliveCor’s enterprise platform allows third-party providers to manage their patients’ and customers’ heart conditions simply using state-of-the-art tools that provide easy front-end and back-end integration to AliveCor technologies, addressing gaps in care and improving the treatment experience for patients across a range of disease areas. AliveCor is a privately held company headquartered in Mountain View, Calif. For more information, visit alivecor.com and follow us on LinkedIn, X, Instagram and Facebook. Media Contactpress@alivecor.com Sales ContactOUSenquiries@aliveor.com A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7436ab48-0e5f-44b7-9289-6bc166f49740
IRVINE, Calif.–(BUSINESS WIRE)–Johnson & Johnson (NYSE: JNJ) today announced the launch of VARIPULSE Pro in Europe following CE Mark approval, further advancing its pulsed field ablation (PFA) portfolio. This new pulse sequence marks the next evolution of the VARIPULSE Platform and is designed to improve procedural efficiencyi,ii while reinforcing its established […]
FORT MILL, S.C., April 06, 2026 (GLOBE NEWSWIRE) — Catheter Precision, Inc. (NYSE American: VTAK) (“VTAK” or the “Company”) today announced that the manuscript titled “Safety and Efficacy of LockeT Suture Retention Device for Large-Bore Venous Access Closure” has been accepted by the Journal of Interventional Cardiac Electrophysiology (JICE), a leading medical journal in the field of electrophysiology. This publication confirmed the safety and efficacy of LockeT for large-bore venous closure in 139 patients and concluded that LockeT demonstrated high procedural success, rapid hemostasis, early ambulation, and low complication rates for venous closure following EP procedures requiring LBVA. These findings support LockeT as a feasible and effective venous closure strategy in contemporary EP practice. David Jenkins, CEO of Catheter Precision, says, “This peer-reviewed validation from JICE reinforces our position that LockeT is a beneficial product for the physicians, patients and hospitals. The acceptance of study data in a prestigious medical journal underscores the importance of the data and enables Catheter Precision to continue its mission of product innovation.” Mr. Jenkins continued, “This additional publication on LockeT technology coupled with expanded hospital interest in both the US and Europe converges into our strategy of unlocking value in this product line.” Last week VTAK announced the engagement of a strategic advisor to assist in the company of exploring various options for its distinctive electrophysiology products. About LockeTCatheter Precision’s LockeT is a suture retention device intended to assist in wound closure after percutaneous venous punctures. LockeT is a Class 1 device registered with the FDA and has received CE Mark approval. About Catheter PrecisionCatheter Precision is an innovative U.S.-based medical device company bringing new solutions to market to improve the treatment of cardiac arrhythmias. It is focused on developing groundbreaking technology for electrophysiology procedures by collaborating with physicians and continuously advancing its products. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “expect,” “anticipate,” “potential,” “will,” “may,” and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, expectations regarding potential strategic transactions, valuation outcomes, market opportunities, and the Company’s growth strategy. These statements involve risks and uncertainties that could cause actual results to differ materially. For a discussion of these risks, please refer to the Company’s filings with the SEC, including its most recent Forms 10-K and 10-Q. The Company undertakes no obligation to update any forward-looking statements. CONTACTS: Investor Relations973-691-2000IR@catheterprecision.com # # #
SAN DIEGO–(BUSINESS WIRE)–Exactice Medical, Inc. today announced a definitive agreement with ImSonic Medical, Inc. to complete advanced prototype development of its AIM device—the industry’s first combined imaging and transseptal access solution, designed to make transseptal procedures faster, safer, and more cost-effective. Exactice’s proprietary AIM device combines 2D/3D intracardiac echocardiography (ICE) with a fully integrated, deployable steerable needle guide. The needle guide remains
