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Vectorious Medical Technologies Announces First U.S. Patient Implanted with the V-LAP Left Atrial Pressure Sensor

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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.

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HeartSciences Announces Allowance of U.S Patent for AI-ECG Assessment of Left Ventricular and Right Ventricular Heart Dysfunction

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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

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Pulse Biosciences, Inc. Announces Receipt of FDA Breakthrough Device Designation for CellFX® nsPFA Cardiac Surgery System for the Treatment of Atrial Fibrillation

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MIAMI–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE) (the “Company” or “Pulse Biosciences”), a company leveraging its novel and proprietary Nanosecond Pulsed Field Ablation™ (nsPFA™) technology, today announced that it has received the Breakthrough Device Designation from the U.S. FDA for the Company’s Cardiac Surgery System for the ablation of cardiac tissue […]

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St. Joseph’s Hospital’s ‘Tampa 2’ AFib Procedure Contributes to Tampa Bay Legacy of Success

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The Tampa 2 procedure was created to be easy to replicate while achieving equal or better outcomes compared to the Cox-Maze IV, a widely used surgical intervention for AFib introduced in 2002. AFib is a cardiac condition noted by an irregular, frequently rapid heart rhythm and is typically treated with prescription, catheter-based and/or surgical interventions. 
“We created the Tampa 2 procedure after years of collaboration between cardiology and cardiac surgery in conjunction with surgical pioneer Dr. James Cox (originator of the Cox-Maze IV procedure). This state-of-the-art technique has the potential to redefine surgical management of atrial fibrillation,” said Dr. Sherman.
Like its predecessor, the Tampa 2 creates scar tissue to block abnormal electrical signals that cause AFib but adds two lines of ablation (the method to create scar tissue) and has a different approach made possible by new tools and technology. The Tampa 2 achieved its namesake because of the two additional lines of ablation, developed by two Tampa physicians, all while tipping their hat to the success the Tampa Bay Buccaneers had with their Tampa 2 defense. More than 50 successful Tampa 2 procedures have been performed at St. Joseph’s Hospital, including the treatment of Brittany Williams, a patient of Dr. Sherman. Now the benefits of the Tampa 2 procedure extend beyond the walls of St. Joseph’s Hospital as Dr. Sherman and Dr. Makati host lectures across the country to train physicians on all aspects of AFib treatment. In addition, the two physicians presented their procedure and clinical findings at the 2024 International Society for Minimally Invasive Cardiothoracic Surgery annual meeting in Athens, Greece (see abstract here).”We are very proud that this novel procedure was developed here at BayCare and St. Joseph’s Hospital,” said Dr. Makati. “We are excited to continually offer new, lifesaving procedures to our community and beyond. This is only possible by the innovative spirit and collaborative efforts of our colleagues here in Tampa and around the world.” For more information about the Heart Institute at St. Joseph’s Hospital: https://baycare.org/locations/hospitals/st-josephs-hospital/services/heart-and-vascular About St. Joseph’s HospitalSt. Joseph’s Hospital, part of the BayCare Health System, is known for advanced medical technology and compassionate care. Its Centers of Excellence include the Heart and Vascular Institute, Cancer Institute, Stroke and Neuroscience Program, Robotic Surgery Program and Emergency/Trauma Department, which provides more emergency care than any other hospital in Tampa Bay. More than 70 specialties are represented among the medical team, including internal medicine, cardiovascular surgery and neurosurgery. The hospital was founded in 1934 by the Franciscan Sisters of Allegany. The 615-bed hospital is located at 3001 West Dr. Martin Luther King Jr. Boulevard in Tampa, Florida. For more information: BayCare.org/SJH.About BayCareBayCare is a leading not-for-profit health care system that connects individuals and families to a wide range of services at 16 hospitals and hundreds of other convenient locations throughout the Tampa Bay and central Florida regions. The system is West Central Florida’s largest provider of behavioral health and pediatric services and its provider group, BayCare Medical Group, is one of the largest in the region. BayCare’s diverse network of ambulatory services includes laboratories, imaging, surgical centers, BayCare Urgent Care locations, wellness centers and one of Florida’s largest home care agencies, BayCare HomeCare. BayCare’s mission is to improve the health of all it serves through community-owned, health care services that set the standard for high-quality, compassionate care. For more information visit BayCare.org.SOURCE BayCare Health System

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Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-AF, an AI-based Algorithm that Identifies Patients at Increased Risk of AFib

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CHICAGO–(BUSINESS WIRE)–Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-AF device that uses AI to help identify patients who may be at increased risk of atrial fibrillation/flutter […]

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Anumana and InfoBionic.Ai Announce Collaboration to Advance AI-powered Remote Cardiac Telemetry Technology for Early Detection of Cardiac Diseases

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CAMBRIDGE, Mass.–(BUSINESS WIRE)–Anumana, a leading AI-driven health technology company and portfolio company of nference, and InfoBionic.Ai, a digital health company specializing in remote cardiac monitoring and diagnostic solutions, today announced a joint research collaboration agreement to develop and commercialize the next generation of remote cardiac care solutions, combining Anumana’s breakthrough ECG-AI™ technology and […]

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Imricor’s VISABL-AFL Trial for US FDA Approval Commences at Cardiovascular Institute of South Paris

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MINNEAPOLIS–(BUSINESS WIRE)–Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) the global leader in real-time iCMR cardiac ablation products, is pleased to announce that the Vision-MR Ablation Catheter 2.0 for Treatment of Type I Atrial Flutter (VISABL-AFL) IDE clinical trial, commenced with two procedures performed at the Cardiovascular Institute of South Paris (ICPS) (https://icps.fr). […]

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AliveCor Announces Dual FDA Clearance of AI Technology That Delivers 35 Cardiac Determinations and First-of-its-Kind Kardia 12L ECG System

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World’s First AI to Detect 35 Cardiac Determinations, Including Heart Attack, Using a Reduced LeadsetPowered by this AI, the Pocket-Sized Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac ConditionsMOUNTAIN VIEW, Calif., June 25, 2024 /PRNewswire/ — AliveCor, the global leader in AI-powered cardiology, today announced the U.S. Food & Drug Administration (FDA) clearance and commercial launch of KAI™ 12L AI technology and the Kardia™ 12L ECG System. This is the world’s first AI that can detect life-threatening cardiac conditions, including heart attacks, using a reduced leadset. The Kardia 12L ECG System, featuring a game-changing patented technology, is the world’s first AI-powered handheld 12-lead electrocardiogram (ECG) system with a unique single-cable design.

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Kardia 12L ECG System Enables Faster, Easier Detection of Life-Threatening Cardiac Conditions Using Reduced Leadset

Pocket-Sized Kardia 12L ECG System

KAI 12L employs multiple deep neural network algorithms, trained and validated on more than 1.75 million ECGs from leading US medical centers. This AI technology can detect 35 cardiac determinations (14 arrhythmias and 21 morphologies), including serious conditions like acute myocardial infarction (MI) and the most common types of cardiac ischemia, using a reduced leadset. KAI 12L can seamlessly integrate with compatible devices, including the Kardia 12L ECG System, expanding critical access to accurate heart data within a broad range of healthcare settings.

“Not only is it the first FDA-cleared AI that can detect a heart attack on a reduced leadset, but it also returns determinations for our broadest range of conditions yet,” said Priya Abani, CEO of AliveCor. “Paired with our pocket-sized Kardia 12L ECG System, this offering is poised to disrupt traditional care pathways and represents a leap forward in cardiac care.”
Kardia 12L ECG System is an innovative solution that requires only a single cable with 5 electrodes to acquire 8 high quality diagnostic bandwidth leads. Conventional 12-lead ECG machines are the standard of care for detecting and diagnosing many heart conditions, but their availability can be limited due to their size and complexity. Using advanced KAI 12L and a reduced leadset, Kardia 12L offers outstanding clinical efficiency and performance substantially equivalent to state-of-the-art ECG analysis solutions. Its speed and simplicity assists healthcare providers in rapid disease detection and enhancing patient experience. “The AI innovations in the Kardia 12L ECG System offer healthcare providers a clinically-validated handheld 12-lead ECG system and expands this critical technology into more resource-limited settings,” said Dr. Stavros Stavrakis, MD, PhD, Professor of Medicine, Division of Cardiology at the University of Oklahoma Health Sciences Center. “By streamlining the process of recording a 12-lead ECG, Kardia 12L has significant implications for rapid ECG diagnosis in clinical practice.”Kardia 12L is battery-operated, weighs just 0.3 pounds and can fit in a pocket – making it significantly smaller, more portable and more convenient than conventional 12-lead ECG machines. 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 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 AliveCorAliveCor, 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.Media ContactsSu Leeslee191@alivecor.com(562) 544-4634Ben Rickles[email protected](404) 502-6766SOURCE AliveCor, Inc.

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Heart Hospital of New Mexico at Lovelace Medical Center and GE HealthCare Collaborate to Install the First Allia IGS Pulse Electrophysiology Lab in the United States for Minimally Invasive Cardiovascular Procedures

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ALBUQUERQUE, N.M.–(BUSINESS WIRE)–Today Heart Hospital of New Mexico at Lovelace Medical Center (HHNM) and GE HealthCare (Nasdaq: GEHC) announced HHNM as the first location in the United States to install GE HealthCare’s latest Allia Image Guided System (IGS) Pulse, which was designed to provide exceptional image quality and improve workflow for the diagnosis and […]

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Vizient examines pulsed field ablation, wearables for women’s cardiovascular health in latest Medical Device Tech Watch

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IRVING, Texas–(BUSINESS WIRE)–Vizient, Inc. examines pulsed field ablation technologies for atrial fibrillation and the role wearable monitoring devices can play in women’s cardiovascular health in the latest Medical Device Tech Watch. “By working closely with providers, we have developed best practices for operationalizing the use of these innovative technologies and tools.” Post […]

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