Amulet 360 helps seal the left atrial appendage (LAA) of a person’s heart, reducing the need for blood-thinning medication Amulet 360 builds upon Abbott’s first-generation LAA device with design updates to enhance how the implant conforms to and seals the LAA to help reduce the risk of a…
Rhythm
Wellness Insights in Your Hands in 60 Seconds: EYVA to Introduce Unique Touch-Based Metabolic Wellness Tracker to U.S. Market – EYVA Pro
The EYVA Pro experience brings together six key wellness indicators with personalized AI-powered insights to help consumers explore the bigger picture across their metabolic, cardiovascular, and respiratory wellness HYDERABAD, India, Aug. 27, 2026 /PRNewswire/ — What if gaining a better…
Catheter Precision Achieves Major Commercial Milestones with Cardinal Health, Johns Hopkins and the placement of the First VIVO System in Germany
Received First LockeT Purchase Order Through Cardinal Health which serves approximately 90% of U.S. Hospitals though its Medical Products business Johns Hopkins Hospital, a world-renowned academic medical center, Places First Order for LockeT, VTAK’s suture retention device Places its first VIVO 3D Imaging System with a hospital in Germany, one of the largest electrophysiology markets in Europe. FORT MILL, S.C., Aug. 27, 2026 (GLOBE NEWSWIRE) — Catheter Precision, Inc.’s (NYSE American: VTAK) medical device business unit specializing in cardiac electrophysiology solutions, today announced significant commercial growth across its LockeT and VIVO product lines, marked by new U.S. distribution channels, premier hospital adoption, and international expansion. Key Commercial Highlights: Cardinal Health Strategic Reach: Catheter Precision received its first purchase order for LockeT via Cardinal Health. As one of the nation’s largest distributors—servicing roughly 90% of U.S. hospitals—Cardinal Health provides LockeT a massive streamlined supply chain network across the U.S. healthcare market.Johns Hopkins Adoption: The Company secured its first purchase order for LockeT from Johns Hopkins in Baltimore MD, validating the clinical value of the device within one of the world’s premier academic medical institutions.German VIVO System Placement: Expanding its European footprint, Catheter Precision signed a new placement contract for its VIVO System in Germany, continuing its strategy to grow international use. “These achievements highlight tangible progress across both our LockeT and VIVO product portfolios,” said David Jenkins, Chief Executive Officer of Catheter Precision. “Securing our first Cardinal Health order grants us immediate access to an extensive domestic distribution network to drive broader market adoption. Concurrently, our milestone order with Johns Hopkins validates our clinical offering, while our new VIVO contract in Germany underscores steady international demand.” Jenkins added, “We are beginning to realize the returns on our commercial infrastructure investments. Our focus remains on driving multi-channel growth through expanded U.S. distribution, direct enterprise hospital relationships, and targeted international expansion. Catheter Precision remains committed to scaling its global footprint across top-tier health systems, physicians, and global distribution partners.” About Catheter Precision, Inc.Catheter Precision, Inc. (NYSE American: VTAK) is an innovative medical device company focused on developing breakthrough solutions for cardiac electrophysiology procedures. Its core product portfolio includes the VIVO™ system, a non-invasive 3D imaging platform designed to assist electrophysiologists in mapping cardiac arrhythmias, and LockeT, a suture retention device designed to assist in vascular closure post-procedure. About LockeTCatheter Precision’s LockeT® is a suture retention device indicated for wound healing by distributing suture tension over a larger area in conjunction with standard-of-care closure techniques. LockeT is intended to temporarily secure sutures and aid clinicians in locating and removing sutures efficiently. LockeT is a sterile Class I product registered with the FDA and has received CE Mark approval. About VIVOCatheter Precision’s VIVO™ (View Into Ventricular Onset) is a non-invasive 3D imaging system that enables physicians to identify the origin of ventricular arrhythmias prior to an electrophysiology procedure, potentially streamlining procedural workflow. VIVO has received marketing clearance from the U.S. FDA and carries the CE Mark. About Catheter PrecisionCatheter Precision, Inc. (NYSE American: VTAK) is an innovative U.S.-based medical device company focused on developing and commercializing technologies designed to improve the treatment of cardiac arrhythmias. The Company’s primary commercial products include the VIVO System and LockeT. Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of applicable federal securities laws. Forward-looking statements include statements regarding the potential commercial adoption of LockeT and VIVO, expansion of distribution channels, future product sales, hospital adoption, international expansion and the potential impact of the Company’s commercial strategy. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Readers are encouraged to review the Company’s filings with the Securities and Exchange Commission, including its Forms 10-K and 10-Q, for additional information regarding these risks. ContactInvestor RelationsIR@catheterprecision.com973-691-2000
Tempus Receives FDA Clearance for its AI Product Intended to Detect Signs of Pulmonary Hypertension From Standard ECGs
CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM) today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for Tempus ECG-PH (pulmonary hypertension), an AI-enabled software device that analyzes standard 12-lead electrocardiograms (ECGs) for signs associated with pulmonary hypertension. Tempus ECG-PH is the third FDA-cleared device in Tempus’ growing cardiovascular portfolio, expanding the company’s suite of next-generation AI products aimed at ide
New Study Demonstrates AliveCor’s KardiaMobile 6L Significantly Increases Arrhythmia Detection Beyond Traditional Ambulatory Monitoring
Peer-reviewed research in JACC Advances reveals patient-initiated, symptom-triggered 6-lead ECG monitoring nearly doubles the diagnostic yield of conventional continuous monitoring modalitiesMOUNTAIN VIEW, Calif., Aug. 20, 2026 (GLOBE NEWSWIRE) — AliveCor, the global leader in AI-powered cardiology, today announced a new prospective cohort study (the M-KEEPS study) conducted by researchers at the University of Rochester Clinical Cardiovascular Research Center and published in JACC Advances. The study, titled “Symptom-Triggered 6-Lead ECG Monitoring Significantly Increases Arrhythmia Detection Beyond Traditional Ambulatory Monitoring,” establishes that 30-day use of the handheld KardiaMobile 6L (KM6L) device outperforms traditional short-duration ambulatory ECG monitoring alone in detecting clinically significant arrhythmias. By empowering patients to capture medical-grade recordings on-demand during symptomatic episodes, the KM6L device achieved an overall diagnostic yield nearly double that of standard clinical monitoring modalities. Key Clinical Findings & Diagnostic YieldThe study evaluated 350 adult patients presenting with unexplained palpitations, dizziness, or lightheadedness who were concurrently tracked using both a physician-ordered standard ambulatory monitor (24/48-hour Holter or an extended patch ECG monitor) and a KM6L device for 30 days. Doubling the Diagnostic Capture: Clinically significant arrhythmias were detected in 66 patients (18.9%) overall across both monitoring types. Traditional ambulatory monitors identified arrhythmias in only 27 patients (7.7%), whereas the KM6L device detected arrhythmias in 52 patients (14.9%) (P < 0.001). Exclusive Arrhythmia Detection: A total of 39 arrhythmia episodes (11.1%) were captured exclusively by the KM6L device and completely missed by conventional continuous monitoring options (p = 0.0008). Outperforming Prolonged Patch Monitors: In an exploratory analysis of patients wearing extended patch ECG monitors for 7 days or longer, the patch devices documented arrhythmias in 9.8% of patients (9 out of 93), while the KM6L device detected arrhythmias in 23.9% of those same patients (22 out of 93) (p 130 bpm)0202Pause1001Total13391466 Redefining the Standard of Care”The M-KEEPS study showed that the KardiaMobile 6L hand-held device enabled patient-initiated ECG recordings with 88% of participants—across a broad range of ages and with two-thirds being women—evaluating the device as easy to use,” said Wojciech Zareba, MD, PhD, of the Clinical Cardiovascular Research Center at the University of Rochester. “Symptom-triggered ECG recordings obtained over 30 days were superior to standard 24- or 48-hour Holter recordings and to prolonged multiday recordings in detecting clinically significant arrhythmias. KM6L might be considered as the first line of diagnostic process in individuals with uncertain causes of cardiac symptoms.” The research team also highlighted how real-world clinical paradigms are shifting toward patient-activated technology to address these exact workflow bottlenecks. “Traditional short-duration monitoring simply misses too many transient events, creating a costly diagnostic blind spot for clinicians,” said Dr. Dave Albert, Chief Medical Officer and Co-founder of AliveCor. “This landmark study from the University of Rochester proves that putting our medical-grade, 6-lead device directly into patients’ hands nearly doubles the diagnostic yield. By empowering patients to capture arrhythmias the moment symptoms occur, we can accelerate accurate diagnoses, optimize clinical workflows, and get patients to life-saving treatment faster—ultimately preventing critical cardiac episodes and the compounding costs of undetected conditions.” High Data Quality and Exceptional Patient UsabilityA critical element of deploying consumer-facing medical technology is patient adherence and signal reliability. Across 6,251 total KM6L recordings collected during the study, 92.3% of the total recordings were deemed clinically interpretable by research technicians. In direct head-to-head temporal alignments, 88.3% of KM6L recordings were classified as top-tier, readable ECGs compared to 86.7% of traditional Holter recordings. Patient survey results at the end of the 30-day testing period indicated massive compliance and clinical satisfaction across a diverse demographic, where two-thirds of study participants were female: 88% of surveyed participants strongly agreed that the KM6L smartphone application was easy to use. 70% strongly agreed that obtaining a 6-lead ECG recording utilizing the left leg electrode was easy to complete. 88% strongly agreed that they felt more confident using the device to actively document their heart rhythms. In practice, the KM6L device functions seamlessly as an adjunct early in the cardiac diagnostic pathway. By reducing repeated short-term monitoring loops, the technology speeds up symptom-rhythm correlation, easing patient anxiety and minimizing unnecessary healthcare expenditures associated with an extended diagnostic search. AliveCor remains deeply committed to anchoring its innovations in rigorous clinical evidence, a dedication backed by more than 250 peer-reviewed articles. The company’s extensive research library, ranging from validation studies in JAMA to landmark trials in The Lancet, consistently proves that its medical-grade AI and hardware improve arrhythmia detection, streamline clinical workflows, and optimize patient outcomes. By continually subjecting its technology to independent scientific scrutiny, AliveCor provides physicians and patients with unmatched, data-driven confidence in remote cardiac care. For clinicians looking for more information on how to integrate Kardia devices into their workflow, visit: https://alivecor.com/health-systems. 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 MathisDirector of Corporate Communications, AliveCorpress@alivecor.com
Murj® Announces Remote Patient Monitoring (RPM) Solution for Cardiovascular Teams
Platform expansion brings exception-based workflows, EHR integration and billing-readiness visibility to remote blood pressure, weight and heart rate monitoring. SAN FRANCISCO, Aug. 18, 2026 /PRNewswire/ — Murj®, a cardiac device management software and services company, today announced…
PercAssist Announces First Patient Enrolled in AVANXA Clinical Feasibility Study using the eVAD™ System for Biventricular Mechanical Circulatory Support
SANTA CLARA, Calif.–(BUSINESS WIRE)–PercAssist, Inc., a medical device company developing innovative technology for extravascular Biventricular Mechanical Circulatory Support to provide hemodynamic improvements for patients in cardiogenic shock (CS), today announced the first patient enrollment for the AVANXA Feasibility Study was successfully conducted in São Paulo, Brazil. “I am thrilled to share the successful clinical use of the PercAssist eVAD System in a patient with SCAI Stage D CS,” s
Kardium Receives Health Canada Approval for the Globe® Pulsed Field System
VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc., a private medical device company that’s advancing the way the world treats atrial fibrillation (AF), announced today that Health Canada has granted a Medical Device Licence for the Globe® Pulsed Field System. Building on the successful U.S. launch of the Globe System following FDA approval in 2025, Health Canada approval marks the next major milestone in expanding access to Kardium’s integrated mapping and pulsed field ablation platfor
Implicity’s Next-Generation ILR ECG Analyzer Earns FDA Clearance
Cloud-based AI algorithm supports implantable cardiac monitors from all major manufacturers, reducing false-positive alerts by up to 76% while maintaining high sensitivity for true events Cambridge, Mass., July 28, 2026 – Implicity, a leader in remote patient monitoring and cardiac data management solutions, today announced that the U.S. Food and […]
B-Secur and CSEM Partner to Bring Clinically-Validated Heart Monitoring to Health Wearables
BELFAST, Northern Ireland & NEUCHÂTEL, Switzerland–(BUSINESS WIRE)– #CardiovascularHealth–B-Secur & CSEM partner to help device makers integrate clinically-validated PPG + ECG heart monitoring into wearables and remote monitoring products.



