The Latest Cardiac and Vascular News
Study evaluates the safety and effectiveness of the OMNYPULSE™ Platform in Europe and Canada Irvine, CA – August 26, 2024 – Biosense Webster, Inc., a global leader in cardiac arrhythmia treatment and part of Johnson & Johnson MedTech,i announced the enrollment completion of the Omny-IRE clinical trial. Omny-IRE is a prospective, multi-center, […]
August 19, 2024 04:01 PM Eastern Daylight Time LAGUNA HILLS, Calif.–(BUSINESS WIRE)–Adagio Medical Holdings, Inc. (Nasdaq: ADGM; the “Company”), a leading innovator in catheter ablation technologies for treatment of cardiac arrhythmias, today provided a business update. “For years there has been underinvestment in and pent-up demand for innovation in ablation […]
ATLANTA–(BUSINESS WIRE)–Zywie, a cardiovascular diagnostics pioneer specializing in remote cardiac monitoring through wearable biosensor devices and cloud-based data analytic solutions, announced today a partnership with MedAxiom, the cardiovascular community’s premier source for organizational performance solutions. “We are proud to welcome Zywie to the MedAxiom community” Post this “We are proud to welcome Zywie to the […]
SAN DIEGO, July 30, 2024 /PRNewswire/ — The HOTWIRE™ RF guidewire device by Atraverse Medical, a San Diego-based medical device company, has been used for the first time in clinical practice by world-renowned cardiac electrophysiologist, Dr. Devi Nair, at St. Bernards Medical Center. The…
Southlake, TX, July 26, 2024 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced an analysis published by the Innovation Value Institute (IVI) titled “Introduction of AI assisted Digital Health Technology to Improve Cardiovascular Pathway Efficiency” focused on the MyoVista® wavECG™’s potential to radically improve the cardiovascular pathway efficiency.
Southlake, TX, July 25, 2024 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that the MyoVista® wavECGTM has been selected by the Innovation Value Institute as a technology which can drive the radical transformation of healthcare and has been invited to demonstrate and discuss the MyoVista wavECG at the 4th Digital Health Symposium at the United Nations General Assembly to be held in New York, USA in September 2024.
Collaboration aims to address challenges in capturing and analyzing cardiac signals to help physicians enhance patient outcomes for atrial fibrillation procedures Collaboration aims to address challenges in capturing and analyzing cardiac signals to help physicians enhance patient outcomes for atrial fibrillation procedures
New Codes Establish Path to Reimbursement for First-of-its-Kind Cardiac Technology
MOUNTAIN VIEW, Calif., July 17, 2024 /PRNewswire/ — AliveCor, the global leader in AI-powered cardiology, today announced that the American Medical Association (AMA) has granted new Category III Current Procedural Terminology (CPT) codes that are applicable to the company’s Kardia™ 12L ECG System, which received FDA clearance in June 2024. In accordance with the AMA semi-annual early release schedule, the new codes will be effective January 1st, 2025 and published in the 2025 CPT Code book.
CPT codes are widely used by government payers, including Medicare and Medicaid, and commercial insurance companies to identify healthcare services and procedures for reimbursement. Category III CPT codes allow data collection for new or emerging healthcare approaches and establish a foundation that facilitates reimbursement pathways for healthcare providers.
The following Category III codes for Kardia 12L were accepted by the CPT Editorial Panel meeting for the 2025 CPT production cycle:
0903T Electrocardiogram, Algorithmically generated 12-lead ECG from a reduced-lead ECG; with interpretation and report
0904T ECG ALG 12 Algorithmically generated 12-lead ECG from a reduced-lead ECG; tracing only
0905T Electrocardiogram, Algorithmically generated 12-lead ECG from a reduced-lead ECG; interpretation and report only
“Cardiovascular disease continues to be the leading cause of death in the US, and this recognition from the AMA brings new momentum towards improving access to life-saving cardiac care, including our latest technology,” said Sanjay Voleti, CBO of AliveCor. “Our AI-powered, portable Kardia 12L is AliveCor’s first device developed exclusively for use by healthcare providers, paving the way to bring this clinically-validated ECG technology to patients anytime and anywhere.”
About Kardia 12L ECG and KAI 12L AI Technology
Kardia 12L ECG System combines the power of KAI 12L’s AI technology and the pocket-sized Kardia 12L, to enable faster, easier detection of life-threatening cardiac conditions. KAI 12L is the world’s first AI to detect 35 cardiac determinations, including heart attacks, using a reduced leadset.
Kardia 12L ECG System is battery-operated, weighs just 0.3 pounds – making it significantly smaller, more portable and easier to use than conventional 12-lead ECGs. Its streamlined leadset also makes it less invasive for patients, who do not need to fully disrobe during a reading. The device requires minimal self-guided training and is simpler and faster to use than standard 12-lead ECG machines. These features put 12-lead ECG data within reach of more healthcare providers than ever before in a variety of healthcare facilities and acute settings, including primary and urgent care offices, employer clinics, and other under-resourced or rural venues.
For healthcare providers interested in purchasing a Kardia 12L, please visit alivecor.com/products/kardia12L.
About AliveCor
AliveCor, Inc., the leading provider of FDA-cleared personal electrocardiogram (ECG) technology, is transforming cardiology with its medical-grade AI solutions. AliveCor is committed to providing innovative devices and services that empower patients and physicians with personalized and actionable heart data. With over 250 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 to detect 35 cardiac conditions (14 arrhythmias and 21 morphologies), 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.
SOURCE AliveCor, Inc.
TEL AVIV, Israel, July 16, 2024 /PRNewswire/ — A patient in Cincinnati has become the first in the United States to receive an innovative system that enables remote monitoring of his heart and congestion status, as well as self-adjustment of diuretics.
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First U.S. Patient Implanted with the V-LAP Left Atrial Pressure Sensor by Vectorious Medical Technologies: A New Treatment Paradigm for Heart Failure Patients
Vectorious Medical Technologies Ltd. developed a miniature pressure sensor that is implanted within the heart via standard minimally invasive transvenous catheterization. The sensor measures Left Atrial Pressure (LAP), the earliest and most accurate indicator of fluid overload and congestion status. The system supports a scalable, physician-directed patient self-management approach, allowing heart failure (HF) patients to take an active role in managing their disease. By using the V-LAP system, patients can better understand their disease and adjust diuretics, daily activities, and fluid volume accordingly.
The first V-LAP implantation in the United States was performed by Sitaramesh Emani, MD, Director of Heart Failure Clinical Trials at The Christ Hospital in Cincinnati, Ohio. To date, 56 V-LAP implantations have been performed, resulting in more than 40,000 days of LAP monitoring. This study, together with the ongoing clinical program in Europe and Israel, will further inform an upcoming U.S. pivotal trial.
“The successful first U.S. V-LAP implantation represents a pivotal moment in heart failure management. By integrating real-time left atrial pressure monitoring into patient care, we are on the cusp of a transformative shift towards more proactive, personalized treatment strategies. This innovative approach aims to improve patient outcomes through a reduction in hospitalizations and enhancement of overall quality of life for heart failure patients, but will do so by empowering patients to actively manage their own care. The data collected from the VECTOR-HF IIb trial will be instrumental in moving our field forward”. Said Dr. Sitaramesh Emani.Initial studies of the V-LAP system, which were recently published in the European Journal of Heart Failure, have shown promising results. During 85% of the overall follow-up duration (26.98 patient-years, 9,593 LAP monitoring days), patient self-management alone, with no physician intervention, was sufficient to keep HF patients without congestion and within safe LAP ranges. This resulted in a significant decrease in the rate of HF-related hospitalizations and a notable improvement in quality of life, based on the 6-minute walk distance and the Kansas City Cardiomyopathy Questionnaire.Eyal Orion, MD, co-founder and CEO of Vectorious, said, “We look forward to expanding our clinical activities in the U.S. and work closely with physicians, nurses, FDA, and our partners towards a pivotal trial. Recent data published in JAMA Cardiology suggests recent plateaus or reversals after long-standing declines in cardiovascular mortality, particularly for HF related mortality in the U.S. between 1999 and 2021. I strongly believe that the technology and Treatment paradigm we develop have the potential to reverse this concerning trend, and our team is fully committed to this mission.”About Vectorious Medical Technologies Ltd.Vectorious is a Tel Aviv-based, privately held company, founded in 2011. The company’s V-LAP System enables heart failure patients to better control their disease by remotely monitoring the heart’s Left Atrial Pressure (LAP) and detecting fluid accumulation in the earliest stages of the disease, prior to physiological symptoms. A patient app further empowers the patient to self-titrate medication in real-time based on data extracted from the heart. For more information, please visit the company website.Contact:Lili Arbely-ElbazVectorious Medical Technologies.+972-(0)525909192[email protected]Photo – https://mma.prnewswire.com/media/2462304/V_LAP_Sensor.jpgSOURCE Vectorious Medical Technologies Ltd.
Southlake, Texas, July 11, 2024 (GLOBE NEWSWIRE) — Heart Test Laboratories, Inc. d/b/a HeartSciences (NASDAQ: HSCS; HSCSW) (“HeartSciences” or the “Company”), an artificial intelligence (AI)-powered medical technology company focused on transforming ECGs/EKGs to save lives through earlier detection of heart disease, today announced that intellectual property (IP) exclusively licensed to HeartSciences has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for the detection of left ventricular (LV) and/or right ventricular (RV) dysfunction using deep learning, further strengthening the Company’s AI-ECG IP portfolio. Heart failure (HF) is a growing worldwide public health issue affecting 64 million people annually1 and is associated with high mortality, lower quality of life and reduced physical capacity while placing substantial costs on the healthcare system. Low-cost testing for heart failure has not been readily available for front-line physicians. With the development of AI-ECG algorithms, HeartSciences improves the early identification of patients that need additional testing, allowing earlier treatment and improved patient outcomes. Andrew Simpson, Chief Executive Officer of HeartSciences, stated, “This patent allowance further expands our extensive AI-ECG IP portfolio. AI-ECG is set to change the detection of heart disease and this latest patent further bolsters value to HeartSciences and our stakeholders.” 1. GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990–2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet 2018;392:1789–1858. About HeartSciences Heart Test Laboratories, Inc. d/b/a HeartSciences is a medical technology company focused on applying innovative AI-based technology to an ECG (also known as an EKG) to expand and improve an ECG’s clinical utility. Millions of ECGs are performed every week and the Company’s objective is to improve healthcare by making it a far more valuable cardiac screening tool, particularly in frontline or point-of-care clinical settings. HeartSciences has one of the largest libraries of AI-ECG algorithms and is developing AI-ECG solutions to be made available on either a hardware agnostic cloud-based platform or its proprietary MyoVista® wavECG™ device, to help identify cardiovascular disease in any care setting worldwide in a manner to best suit different care providers. HeartSciences’ first product candidate for FDA clearance, the MyoVista® wavECG™, or the MyoVista®, is a resting 12-lead ECG that is also designed to provide diagnostic information related to cardiac dysfunction which has traditionally only been available through the use of cardiac imaging. The MyoVista® also provides conventional ECG information in the same test. For more information, please visit: https://heartsciences.com/. X: @HeartSciences Safe Harbor Statement This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements are made under the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and are relating to the Company’s future financial and operating performance. All statements, other than statements of historical facts, included herein are “forward-looking statements” including, among other things, statements about HeartSciences’ beliefs and expectations. These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. The expectations reflected in these forward-looking statements involve significant assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Investors should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Potential risks and uncertainties include, but are not limited to, risks discussed in HeartSciences’ Annual Report on Form 10-K for the fiscal year ended April 30, 2023, filed with the U.S. Securities and Exchange Commission (the “SEC”) on July 18, 2023, HeartSciences’ Quarterly Report on Form 10-Q for the fiscal quarter ended January 31, 2024, filed with the SEC on March 14, 2024 and in HeartSciences’ other filings with the SEC at www.sec.gov. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements. Contacts: HeartSciencesGene Gephart+1-682-244-2578 (US)info@heartsciences.com Investors: Gilmartin GroupVivian Cervantesinvestorrelations@heartsciences.com
