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

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 […]

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

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). […]

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

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.

Avive Solutions, Inc. Welcomes Mark Peters as New Vice President of Sales

SAN FRANCISCO, June 25, 2024 /PRNewswire/ — Avive Solutions, Inc., a manufacturer of innovative Automated External Defibrillators (AEDs) and software solutions to improve access to AEDs and response to cardiac arrest emergencies, is excited to announce the appointment of Mark Peters as their new Vice President of Sales. A highly-regarded sales leader in the AED, medical device, and public safety industries, Peters brings with him a wealth of experience building and leading high-performing sales teams and an impressive track record of driving commercial and strategic growth.
“I am thrilled to join Avive’s leadership team and bring both my professional experience and personal passion for the proliferation of AEDs to the company at this exciting time in their journey,” said Peters. “For years, there have been millions of AEDs out in the world with very little change in Sudden Cardiac Arrest survival rates. Avive is the only AED company innovating on new ways to change the outlook for Sudden Cardiac Arrest response, now and into the future. It has been incredible to watch the founders take their mission to democratize defibrillation from concept to reality, with the first truly new technological advancement in the AED space in over 20 years.”
After losing a close friend to Sudden Cardiac Arrest (SCA) in 2000, Peters suffered Sudden Cardiac Arrest himself in 2009 and was fortunate to survive, an event that altered the trajectory of his life. Since then, he has devoted his career to increasing the presence of this lifesaving device throughout the nation, beginning with a role as an Account Executive on the sales team at AED manufacturer Cardiac Science. Over the subsequent 8.5 years, Peters ascended the sales ranks quickly, culminating in a role as Senior Director of U.S. Distribution and Strategic Growth, overseeing a high-performing national sales team and the company’s channel expansion strategy. Peters and his team achieved exemplary performance and increased the company’s market share significantly during his tenure, culminating in an acquisition by ZOLL Medical in 2019. Since then, Peters has held a variety of executive sales leadership roles in the public safety field, showcasing his expertise in sales and go to market strategy, market growth, and strategic partnerships in service of making public safety and lifesaving tools and technologies more readily available throughout the nation.
“We are excited to have Mark join our leadership team at Avive, where he not only brings tremendous domain expertise from his time at Cardiac Science, but also a proven track record of building high-performing and customer centric sales teams,” said Sameer Jafri, Avive’s co-founder and CEO. “He is taking the leadership reins of our sales team at the perfect time in our company’s journey, as he will play a key role in continuing to drive and catalyze our rapid commercial ramp in the U.S.”
As Peters takes the helm of the Sales team at Avive Solutions, Inc., he is singularly focused on developing the most knowledgeable and customer-centric, consultative sales team in the industry, while keeping Avive’s mission to increase the presence of lifesaving AEDs and save more lives front and center at all times. “Simply put, Avive is mission-driven and mission-first,” he said. “The proliferation of AEDs over the past couple of decades has unfortunately not correlated to increased SCA survival rates. Now, Avive is fundamentally changing the way the entire AED industry thinks about response and survival. My mission here will be to drive market adoption in key verticals to make more Avive AEDs accessible to everyone, ultimately helping us have a tangible, positive impact on SCA survival rates and saving countless lives.”
About Avive Solutions, Inc.
Avive Solutions is a new kind of AED company, revolutionizing Sudden Cardiac Arrest response with an innovative platform that brings together a 21st-century AED device and a first-of-its-kind software solution. With their award-winning product, the Avive Connect AED, Avive is the first new company to bring an AED to market in the U.S. in over 20 years. Focused on portability, accessibility, and connectivity, the Avive Connect AED is one of the most advanced products in the industry. Additionally, Avive’s software solutions not only make owning and managing AEDs simple, they also deliver a comprehensive cardiac arrest response solution to communities, with the goal of increasing bystander intervention, decreasing time-to-defibrillation, and transmitting valuable data to the people who need it, when they need it. Founded in 2017, Avive is on a mission to empower bystanders, first responders, and 911 telecommunicators to provide lifesaving care as quickly and easily as possible. Learn more at avive.life.
Media Contact:Kyle Noble[email protected] (415) 287-6881
SOURCE Avive Solutions, Inc.

Data Supporting Nanox.AI Cardiac Solution to Be Presented at 19th Annual Meeting of the Society of Cardiovascular Computed Tomography

PETACH TIKVA, Israel, June 25, 2024 (GLOBE NEWSWIRE) — NANO-X IMAGING LTD (“Nanox” or the “Company,” Nasdaq: NNOX), an innovative medical imaging technology company, today announced that data from five studies supporting the AI Cardiac Solution (HealthCCSng) of its subsidiary, Nanox AI, will be presented at the 19th Annual Meeting of the Society of Cardiovascular Computed Tomography (SCCT), being held July 18-21 in Washington, D.C. The studies are being presented by esteemed institutions Brigham & Women’s Hospital, Einstein Jefferson Medical Center, Corewell Health, Massachusetts General Hospital and Beilinson Medical Center. Nanox AI’s Cardiac Solution (HealthCCSng) utilizes medical imaging data from routine chest CT scans to automatically quantify coronary artery calcium (CAC) levels. CAC is known as a strong predictor of future cardiovascular events; patients in the highest CAC category are up to 6x more likely to suffer cardiac events. The abstract details are as follows: Title: The Frequency, Prevalence, And Outcomes of Incidentally Detected Coronary Artery Calcium Using Artificial Intelligence Analysis Among Patients with Immune Mediated Inflammatory Diseases (Best Abstract Award Finalist)Lead Author: Brittany Weber, Brigham & Women’s HospitalAbstract number: 2024-A-817-SCCTPresentation date and time: Saturday, July 20, 10:30 AM, Liberty I-M Title: Optimizing Preventive Cardiology: Harnessing AI for Early Detection of Coronary Artery DiseaseLead author: Dr. Chiduzie Madubata, Einstein Jefferson Medical CenterAbstract number: 2024-A-573-SCCTPresentation date and time: Friday, July 19, 9:30AM – 10:15AM, Exhibit Hall Title: AI Empowering Early Detection of CAD Patients for Improved Cardiac CareLead author: Dr. David Langholz, Corewell HealthAbstract number: 2024-A-641-SCCTPresentation date and time: Friday, July 19, 9:30AM – 10:15AM, Exhibit Hall Title: Artificial-intelligence Based Detection of Coronary Artery Calcium on Chest CT to Enhance Cardiovascular Risk Assessment of Individuals with Elevated Lipoprotein (a)Lead author: Milena Petranovic, Massachusetts General HospitalAbstract number: 2024-A-820-SCCTPresentation date and time: Friday, July 19, 9:30AM – 10:15AM, Exhibit Hall Title: Opportunistic Screening of Coronary Artery Calcification On Non-gated Conventional CT Scans Using Artificial IntelligenceLead author: Dr. Ashraf Hamdan, Beilinson HospitalAbstract number: 2024-A-532-SCCTPresentation date and time: Saturday, July 20, 9:30AM – 10:15AM, Exhibit Hall  Throughout SCCT, Nanox AI’s representative will also be available for meetings in the Honeysuckle Meeting Room. You can schedule a meeting here. About Nanox AINanox AI is the deep-learning medical imaging analytics subsidiary of Nanox. Nanox AI’s solutions are developed to target highly prevalent chronic and acute diseases affecting large populations around the world. Leveraging AI technology, Nanox AI helps clinicians extract valuable and actionable clinical insights from routine medical imaging that otherwise may go unnoticed, potentially initiating further medical assessment to establish individual preventative care pathways for patients. For more information, please visit https://www.nanox.vision/ai. About NanoxNanox (NASDAQ: NNOX) is focused on applying its proprietary medical imaging technology and solutions to make diagnostic medicine more accessible and affordable across the globe. Nanox’s vision is to increase access, reduce costs and enhance the efficiency of routine medical imaging technology and processes, in order to improve early detection and treatment, which Nanox believes is key to helping people achieve better health outcomes, and, ultimately, to save lives. The Nanox ecosystem includes Nanox.ARC— a multi-source Digital Tomosynthesis system that is cost-effective and user-friendly; an AI-based suite of algorithms that augment the readings of routine CT imaging to highlight early signs often related to chronic disease (Nanox.AI); a cloud-based infrastructure (Nanox.CLOUD); and a proprietary decentralized marketplace, through Nanox’s subsidiary, USARAD Holdings Inc., that provides remote access to radiology and cardiology experts; and a comprehensive teleradiology services platform (Nanox.MARKETPLACE). Together, Nanox’s products and services create a worldwide, innovative, and comprehensive solution that connects medical imaging solutions, from scan to diagnosis. For more information, please visit www.nanox.vision. Contacts Media Contact:Ben ShannonICR WestwickeNanoxPR@icrinc.com Investor Contact:Mike CavanaughICR Westwickemike.cavanaugh@westwicke.com

CVRx Announces Appointment of Robert Allen John as Chief Revenue Officer

MINNEAPOLIS, June 25, 2024 (GLOBE NEWSWIRE) — CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company, today announced the appointment of Robert John as Chief Revenue Officer effective June 27. In this role, John will lead the Company’s US sales team with the objective of maximizing the positive impact of Barostim therapy on patients suffering from heart failure and establishing Barostim as standard of care in the United States. “We are thrilled to welcome Robert to the CVRx executive team as we continue to expand the adoption of Barostim therapy,” said Kevin Hykes, President and CEO of CVRx. “Robert is well-known and respected within the heart failure community and has extensive experience building global sales organizations, launching novel heart failure therapies, and delivering results. He will be invaluable as we accelerate our commercial momentum.” John brings over 25 years of sales leadership experience in the medical device industry, with a strong track record of building high-performing sales teams. Most recently, he served as Divisional Vice President and General Manager of Cardiac Rhythm Management EMEA at Abbott, where he led a global business unit spanning over 90 countries. Prior to this role, he was first Senior Vice President, then the Divisional Vice President of the Heart Failure business, responsible for integrating the Thoratec and CardioMEMs businesses and leading the commercial teams for St. Jude, then at Abbott post-acquisition. Prior to the acquisition, John held multiple commercial leadership positions at St. Jude Medical across the Cardiac Rhythm, Electrophysiology, Capital, Structural Heart, Vascular and Heart Failure businesses. Prior to Abbott/St. Jude, John held commercial roles at Medtronic, Guidant and Pfizer. He holds a Bachelor of Science from the University of North Texas and a Master of Arts in Human Resources Management from the University of Alabama, Tuscaloosa. “I am excited to join CVRx at this pivotal time for the company and the patients we serve,” said Robert John. “Throughout my career, I have been passionate about bringing innovative therapies to market that can significantly improve patient outcomes. CVRx’s Barostim therapy is a truly revolutionary technology with the potential to transform the treatment of heart failure. I look forward to working with the talented CVRx team to make this groundbreaking therapy available to more patients and drive the next phase of the company’s growth.” About CVRx, Inc. CVRx is focused on the development and commercialization of the Barostim™ System, the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. Baroreceptors activate the body’s baroreflex, which in turn triggers an autonomic response to the heart. The therapy is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com. Investor Contact: Mark Klausner or Mike VallieICR Westwicke443-213-0501ir@cvrx.com Media Contact: Laura O’NeillFinn Partners402-499-8203laura.oneill@finnpartners.com

Milestone Phase II Clinical Study Demonstrates Niagen®, Patented Nicotinamide Riboside (NR), Improves Functional Mobility for Individuals with Peripheral Artery Disease (PAD)

June 24, 2024 08:32 AM Eastern Daylight Time LOS ANGELES–(BUSINESS WIRE)–ChromaDex Corp. (NASDAQ:CDXC), the global authority on nicotinamide adenine dinucleotide (NAD+) research, shares results from a milestone phase II clinical study showcasing the promising effects of nicotinamide riboside (NR) supplementation for people with peripheral artery disease (PAD). This study was […]

Alnylam Reports Positive Topline Results from HELIOS-B Phase 3 Study of Vutrisiran, Achieving Statistical Significance on Primary and All Secondary Endpoints in Both Overall and Monotherapy Populations

June 24, 2024 07:00 AM Eastern Daylight Time CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM). Alnylam Reports Positive […]

HeartFocus Joins Butterfly Garden to Develop Software Enabling Any Healthcare Professional to Conduct Lifesaving Echos on Butterfly’s Imaging Platform

June 24, 2024 07:00 AM Eastern Daylight Time BORDEAUX, France–(BUSINESS WIRE)–HeartFocus, the revolutionary, AI-driven heart exam software by DESKi, a provider of automated, accurate, and data-driven image analysis tools today announced it has joined Butterfly Garden, an artificial intelligence (AI) Marketplace launched by Butterfly Network, Inc., (“Butterfly”) (NYSE: BFLY) a digital health […]

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

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 […]