Author: Ken Dropiewski

Bioxodes meets first Phase 2a patient enrollment milestone with BIOX-101 in intracerebral hemorrhagic stroke

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 First-in-class drug candidate evaluated in first eight patients Gosselies (Belgium), June 27, 2024 – Bioxodes SA, a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases, announces today that it has enrolled the first eight of 32 patients in a Phase 2a clinical study of its lead asset BIOX-101 (Ir-CPI). The study is evaluating BIOX-101 in intracerebral hemorrhagic stroke (ICH), a devastating condition for which there is currently no available treatment. Reaching this first milestone allows Bioxodes to conduct an initial analysis of pharmacokinetic and pharmacodynamic data to evaluate the dose-response and preliminary clinical proof-of concept of the therapeutic candidate, as well as safety in this patient population. “For the first time, we are able to assess the preliminary results of BIOX-101 in ICH patients, who up until now have had very few treatment options. Analysis of these first 8 patients will yield preliminary proof-of-concept data for BIOX-101, a first-in-class drug candidate derived from a protein found in the saliva of the tick 1, designed to prevent the harmful secondary brain injuries that occur after a hemorrhagic stroke,” said Marc Dechamps, Chief Executive Officer at Bioxodes. The study, conducted in 10 stroke units in Belgium and led by Prof Robin Lemmens, a world-leading stroke authority and head of the clinic at the University Hospital Leuven, aims to enroll 32 patients aged 18 and above, with 24 receiving BIOX-101, and 8 standard-of-care treatment. The trial is a randomized, open-label proof-of-concept study, and will evaluate the safety and tolerability of BIOX-101 in patients with spontaneous ICH, while also generating preliminary data on secondary efficacy objectives. All patients will be monitored for at least one year to evaluate the impact of the treatment on long-term functional outcomes. Interim results for the first 16 patients are expected by the fourth quarter of 2024. BIOX-101 prevents blood clot formation without increasing the risk of further bleeding. Moreover, by inhibiting the activation of neutrophils, a type of white blood cell that often act as the first responders of the inflammatory system, it also prevents the acute neuroinflammatory events associated with ICH. BIOX-101 is also in early development as a platform for a series of other indications, including ischemic stroke and other thrombo-inflammatory diseases. KEY FACTS ABOUT STROKE:* 15 million people worldwide suffer from a stroke each year, * Of those, 5 million die, another 5 million are left severely disabled* Stroke is the leading cause of disability among neurological conditions worldwide, according to the Global Burden of Disease Study 2021 (Lancet Neurology May 2024).* Two types: ischemic stroke (caused by a blood clot) and hemorrhagic stroke (ruptured vessel)* Hemorrhagic stroke makes up 13% of all cases, but causes 40% of deaths* Intracerebral hemorrhagic stroke (ICH) is by far the most common type of hemorrhagic stroke * For hemorrhagic stroke, there is little other to do than surgery, with poor outcomes* Bioxodes has applied for an orphan disease designation for BIOX-101 in the US and EU. Being awarded the designation could accelerate the regulatory approval process. 1 Ixodes ricinus About Bioxodes Bioxodes is a clinical stage biopharmaceutical company developing novel therapies for the prevention and treatment of thrombotic and inflammatory diseases. Since its founding in 2013, Bioxodes has developed its lead asset BIOX-101, a first-in-class drug candidate aimed at patients with thrombo-inflammatory disease. BIOX-101’s unique mechanism of action is the foundation of an innovative pipeline of drug candidates for the prevention of (thrombo)inflammatory diseases. The company, which is based in the biopark of Gosselies near Brussels in Belgium, has so far secured €34 million in funding from Belgian investment funds and business angels, including €12 million in non-dilutive funding from the Wallonia region. Worldwide, Bioxodes holds both granted and pending patents associated with BIOX-101. http://www.bioxodes.com/ For more information please contact: HEAD OFFICESBioPark Charleroi-Bruxelles SudRue Santos-Dumont, 16041 Gosselies, Belgium+32 496 590354investment@bioxodes.com MEDIA RELATIONSAlexandra Schiettekatte alexandra.alicato@outlook.com+32 476 65 04 38COHESION BUREAUEU MEDIA RELATIONSSophie Baumontsophie.baumont@cohesionbureau.comINVESTOR RELATIONSGiovanni Ca’ Zorzigiovanni.cazorzi@cohesionbureau.com   
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20240627 Bioxodes PR first 8 patients (final) EN

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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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American College of Radiology Launches First Medical Practice Artificial Intelligence Quality Assurance Program

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ARCH-AI Can Help Radiology Sites Safely and Effectively Implement AI in Daily Practice
RESTON, Va., June 26, 2024 /PRNewswire/ — The American College of Radiology® (ACR®) today launched the ACR Recognized Center for Healthcare-AI (ARCH-AI), the first national artificial intelligence quality assurance program for radiology facilities.
The program, built on best practices, outlines expert consensus-based building blocks of infrastructure, processes and governance in AI implementation in real-world practice.
By working toward, and attesting to, compliance within the tenets of the program, participation in ARCH-AI can help radiology practices provide safe and effective implementation of AI products and help radiologists provide better patient care.  
“AI is different from previous technologies,” said Christoph Wald, MD, PhD, MBA, FACR, vice chair of the ACR Board of Chancellors and chair of the ACR Commission on Informatics. “Even a U.S. Food and Drug Administration-cleared AI product must be tested locally to ensure it works safely and as intended. Practice leaders must put safeguards in place to maximize the benefit of AI products while minimizing risk; ARCH-AI is a low-cost, efficient system to help sites do that.”
ARCH-AI site recognition criteria include:

Establishing an interdisciplinary AI governance group.
Maintaining an inventory of AI algorithms with detailed documentation.
Ensuring adherence to security and compliance measures.
Engaging in diligent review and selection of AI algorithms.
Documenting use cases and training procedures.
Monitoring algorithm performance, including safety and effectiveness.
Contributing to the “Assess-AI” central AI registry for performance benchmarking.

“ARCH-AI can help radiology practices structure QA processes that help them plan for what can go wrong, including the development of good AI governance practices, acceptance testing and effectiveness monitoring of AI products to ensure they continue to function as expected over time,” said Keith J. Dreyer, DO, PhD, FACR, ACR Data Science Institute® (DSI®) chief science officer.
Radiology practices that complete the ARCH-AI process will receive an ACR Recognition badge to display in their waiting rooms and lobbies to demonstrate to their communities, patients, payers and referring physicians that they are committed to integrating AI in a safe, responsible manner that allows them to provide the best possible modern healthcare.
“ARCH-AI provides a great blueprint and assists radiology facilities with AI implementation,” said Bibb Allen Jr., MD, FACR, ACR DSI chief medical officer. “DSI also offers AICentral.org, a database of FDA-cleared imaging AI products, and Assess-AI, the ACR’s AI registry that can support local AI acceptance testing and monitoring. These ACR programs can help practices meet ARCH-AI standards and receive meaningful guidance and assistance in implementing AI in a safe and effective manner for their patients.”
SOURCE American College of Radiology

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Rep. Hillary Scholten and the National Blood Clot Alliance Award Corewell Health Butterworth Hospital as a VTE Center of Excellence

Peripheral/Endo by Comments are Disabled

GRAND RAPIDS, Mich., June 26, 2024 /PRNewswire/ — On June 24, 2024, Rep. Hillary Scholten (MI-03) joined members of the National Blood Clot Alliance “NBCA” (www.stoptheclot.org) to present NBCA’s inaugural Venous Thromboembolism (VTE) Center of Excellence (COE) award to Corewell Health Grand Rapids Hospitals – Butterworth Hospital. This award recognizes the hospital’s outstanding commitment to providing the highest standard of care, patient education, and follow-up treatment for VTE patients.

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Rep. Hillary Scholten (MI-03) (center) presents the inaugural NBCA VTE Center of Excellence Award to the Corewell Health team. Pictured from left to right: Glen VanOtteren, Erin VanDyke, PA-C, MPAS, Michael Knox, MD, and Trevor Cummings, MD, FACEP.

Rep. Scholten stated, “Our friends, families, neighbors, and the wider community can trust the commitment to excellence demonstrated by Corewell’s clinicians.  These incredible providers ensure that all patients, not just some, will receive the highest standard of care when being diagnosed and treated for VTE.  I was delighted to submit a FY25 appropriations request to fund a nationwide public awareness campaign and to train healthcare providers to recognize the symptoms of blood clots. West Michigan is leading the way in addressing this public health crisis, setting a model for both the Great Lakes State and our nation.”

Dr. Michael Knox, MD, FACR, and Co-Director of the Corewell PERT Program, accepted the award on behalf of Corewell. He stated, “I am honored to accept this award on behalf of my team and thank NBCA for this distinction. We appreciate Rep. Scholten’s acknowledgement of the important work we are doing. Tackling this public health crisis will take all of us working together — hospitals, clinicians, patients, and Members of Congress.”
Justin Crockett, NBCA Board Member and Chair of the NBCA VTE COE Committee, added, “Development of this VTE COE designation has been a long journey. We are very proud to present this award and to start reducing the incidence and mortality of VTE, which claims the lives of 100,000 people each year from all age groups and walks of life. We are especially grateful for Congresswoman Scholten’s support and in recognizing the toll VTE takes on both the citizens of Michigan and the entire nation. We also thank her for supporting NBCA’s $5 million federal appropriations request directing funding to the Centers for Disease Control and Prevention’s (CDC) Division of Blood Disorders and Genomics for a national VTE education, awareness, and prevention program for both the public and clinicians.”VTE (venous blood clots) claims the lives of 100,000 Americans each year while impacting another 900,000 individuals. It is the third leading cause of cardiovascular death and the second cause of sudden unexpected death. It kills more people each year than HIV/AIDS, breast cancer and motor vehicle accidents combined. Nearly half of all VTE cases occur in a hospital or post-hospital setting, yet, according to the CDC, 70% of these cases are preventable.  It is estimated that the annual cost to the US healthcare system is $10 billion per annum.About the National Blood Clot Alliance The National Blood Clot Alliance, established in 2003, is the nation’s leading nonprofit, patient advocacy organization dedicated to advancing the prevention, early diagnosis, and successful treatment of life-threatening blood clots, such as deep vein thrombosis (DVT) and pulmonary embolism (PE), DVT +PE=VTE. Each year NBCA provides blood clot information, resources, and support to more than 3 million people. For more information about NBCA please contact [email protected] or visit www.stoptheclot.org.About Corewell Health™People are at the heart of everything we do, and the inspiration for our legacy of outstanding outcomes, innovation, strong community partnerships, philanthropy and transparency. Corewell Health is a not-for-profit health system that provides health care and coverage with an exceptional team of 65,000+ dedicated people—including more than 12,000 physicians and advanced practice providers and more than 15,500 nurses providing care and services in 21 hospitals, 300+ outpatient locations and several post-acute facilities—and Priority Health, a provider-sponsored health plan serving more than 1.3 million members. Through experience and collaboration, we are reimagining a better, more equitable model of health and wellness. For more information, visit www.corewellhealth.org.About Rep. Hillary Scholten:Congresswoman Hillary J. Scholten is honored to serve the people of Michigan’s Third Congressional District, a diverse district that is anchored by the urban centers of Grand Rapids, Muskegon, and Grand Haven, and includes suburbs, farmland, and miles of beautiful Lake Michigan shoreline.Congresswoman Scholten is a fourth-generation West Michigander.  For more information visit www.hillaryscholten.com.SOURCE National Blood Clot Alliance

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Fort Sanders Regional Medical Center First in Tennessee to Adopt New Cardiac Angiogram Technology

Coronary/Structural Heart Uncategorized by Comments are Disabled

KNOXVILLE, Tenn., June 26, 2024 /PRNewswire/ — Fort Sanders Regional Medical Center, a member of Knoxville-based Covenant Health, was the first hospital in the state of Tennessee to adopt revolutionary diagnostic technology that provides clinicians with a patient’s physiology results in just a few minutes.
Coronary heart disease is one of the top killers of adults in the U.S. and particularly the Southeast. Quick diagnosis and intervention are key to treating cardiac patients who are suffering from heart disease, heart attack, or other events causing blockages in arteries that can be life-threatening.
Fort Sanders Regional’s cardiac catheterization lab is staffed around the clock, 24/7, treating both heart patients who have been admitted to the hospital and those who are having outpatient procedures.
When a patient presents with a potential artery blockage, the heart team at Fort Sanders Regional can use a new tool that shows doctors exactly what percentage of an artery is blocked. The CathWorks FFRangio ® System is a computer-based technology that uses routine angiograms (images) of a patient’s heart structure to create a 3D model showing the location and degree of any blockages and their coronary arteries. This helps providers more quickly diagnose and intervene as needed, including determining whether the patient needs a stent and where the stent should be placed in the heart structure.
Fractional flow reserve (FFR) is a diagnostic measurement that evaluates the physiologic impact of coronary artery narrowing due to cholesterol plaque. It is an important part of the decision-making process to decide if a stent placement is indicated and the length of the stent when managing patients with coronary artery disease (CAD).
In contrast to traditional FFR, the FFRangio System combines artificial intelligence (AI) and advanced computational science to obtain quick and reliable FFRangio values from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. The system provides physicians intraprocedural FFRangio values for all coronary arteries.
Josh Todd, MD, interventional cardiologist at Fort Sanders Regional, said, “With this new tool, interventional cardiologists can perform clinical assessments quicker, more comprehensively, without medications, and in a way that’s seamless and more efficient to the patient. This cutting-edge technology will transform how cardiovascular disease is diagnosed and treated.”
To view the full release, visit https://www.covenanthealth.com/blog/cathworks-technology/.
SOURCE Covenant Health

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Rivus Pharmaceuticals Announces Publication of Phase 2a HuMAIN Trial Rationale and Design in European Journal of Heart Failure

Coronary/Structural Heart by Comments are Disabled

– Study evaluating HU6 in patients with obesity-related heart failure with preserved ejection fraction is on track to report topline data in the second half of 2024 –
– HU6, a novel Controlled Metabolic Accelerator, is a new class of investigational medicines designed to reduce weight while preserving muscle –
CHARLOTTESVILLE, Va. and SAN FRANCISCO, June 26, 2024 /PRNewswire/ — Rivus Pharmaceuticals Inc., a clinical-stage biopharmaceutical company dedicated to improving metabolic health, today announced publication of the rationale and design of the company’s Phase 2a HuMAIN trial in the European Journal of Heart Failure. Rivus has completed patient enrollment in this clinical trial of HU6, an investigational Controlled Metabolic Accelerator (CMA), in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) and expects to report topline data in the second half of 2024.
“HuMAIN is the first clinical trial to evaluate the effects of a CMA in patients with obesity-related HFpEF, who have a median survival rate of around two years following hospitalization,” said Jayson Dallas, M.D., chief executive officer, Rivus Pharmaceuticals. “HU6 has the potential to be the first disease-modifying treatment for HFpEF. We look forward to further evaluating the potential benefits of HU6 in this large and growing patient population and sharing topline results in the second half of 2024.”
HFpEF is a chronic debilitating syndrome characterized by severely reduced exercise capacity, which degrades quality of life. Obesity is a major independent risk factor for HFpEF and key contributor to the increasing worldwide prevalence of this disorder, with as many as 80% of patients with HFpEF in Western countries either overweight or obese. Weight loss approaches that involve dieting, bariatric surgery and GLP-1 agonists work by decreasing energy intake rather than by increasing energy expenditure. In addition to loss of fat, these approaches result in marked reductions in muscle mass, which can lead to impaired function in patients with HFpEF, who are typically elderly and frail and already have reduced muscle mass.
“Given the limitations of current options for patients with obesity-related HFpEF, novel disease-modifying treatments are urgently needed,” said Dalane W. Kitzman, M.D., lead author of the publication and professor of internal medicine and cardiovascular medicine at Wake Forest University School of Medicine. “As detailed in this new publication, HU6 reduces fat, which is pivotal to the development of HFpEF, by increasing energy expenditure while preserving muscle. The Phase 2a trial will examine HU6’s potential to improve key outcomes in HFpEF, including increasing exercise capacity and quality of life, reducing systemic inflammation, and improving blood pressure and glucose metabolism.”
About the Phase 2a HuMAIN TrialThe randomized, double-blind, placebo-controlled, parallel-group, dose-escalation Phase 2a HuMAIN study (ClinicalTrials.gov: NCT05284617) is evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of ascending doses of HU6 (150 mg, 300 mg, 450 mg daily) in patients with obesity-related HFpEF. A total of 65 study participants (37 women and 28 men) age 30 or older with a body mass index (BMI)  >30 kg/m2 were randomized to 134 days of daily dosing with HU6 or placebo.
The primary efficacy endpoint is weight reduction (as measured by the change from baseline in body weight at Day 134). The key secondary efficacy endpoint is exercise capacity (as measured by the change from baseline in peak VO2 [mL/kg/min] during a standardized, noninvasive cardiopulmonary exercise test at Day 134). The effects of HU6 on disease-specific quality of life, changes in body composition and cardiac function/structure, and markers of cardiometabolic dysfunction (e.g., changes in blood pressure and pulse, glucose control, inflammation, lipid levels and liver fat and liver enzymes) are also being evaluated. The study is designed to identify the optimal dose of HU6 for Phase 3 trials. HuMAIN is being conducted at 22 clinical sites in the United States.
About Controlled Metabolic Accelerators (CMAs)Rivus is advancing a new class of investigational medicines called Controlled Metabolic Accelerators (CMAs) that have the potential to improve metabolic health for people with obesity and associated metabolic diseases. CMAs are oral small molecules designed to increase resting metabolic rate, which results in increased consumption of energy, primarily from fat. The loss in fat mass addresses multiple cardiometabolic conditions driven by adiposity. CMAs increase metabolism in a continuous and imperceptible manner by leveraging the natural metabolic process of mitochondrial uncoupling. Uncoupling accounts for 20%-40% of resting caloric consumption. A key advantage of this mechanism for increasing energy expenditure is that the resulting weight loss is fat selective with preservation of muscle mass. In contrast, caloric-restriction strategies reduce energy input and result in loss of fat as well as muscle mass. Initial data in humans has demonstrated that CMAs provide fat-selective weight loss, improved insulin sensitivity, and a significant reduction in oxidative stress and inflammation.
About HU6HU6, an oral, once-daily investigational medicine, is Rivus’ lead CMA. It is a purposely designed investigational oral small molecule that is intended to be a foundational monotherapy for cardiac, liver, diabetes and obesity indications. HU6 promotes sustained weight loss by gently, safely and imperceptibly increasing resting metabolism, which results in fat burn, while preserving muscle mass. Phase 2 results in patients with a high body mass index (BMI) and metabolic dysfunction-associated steatotic liver disease (MASLD) showed that once-daily HU6 significantly reduced liver fat content and body weight with no loss of lean muscle mass and improved key markers of systemic inflammation and metabolism.1 HU6 was well tolerated; side effects were mainly mild or moderate in severity.
The current clinical development of HU6 is focused on metabolic diseases with the most morbidity and greatest treatment needs: heart failure with preserved ejection fraction (HFpEF) and metabolic dysfunction-associated steatohepatitis (MASH)/MASLD.
About Rivus PharmaceuticalsRivus Pharmaceuticals, Inc., a leader in mitochondrial biology, is dedicated to improving metabolic health by advancing a new class of investigational medicines called Controlled Metabolic Accelerators (CMAs). Rivus’ lead CMA is the investigational small molecule HU6 in development to treat heart failure with preserved ejection fraction (HFpEF), metabolic dysfunction-associated steatotic liver disease (MASLD)/metabolic dysfunction-associated steatohepatitis (MASH) and Type 2 diabetes. For more information, please visit www.rivuspharma.com.
Contact:Meredith MallenReal Chemistry[email protected]+1-516-987-2313
References

Noureddin M, Khan S, Portell F, et al. Safety and efficacy of once-daily HU6 versus placebo in people with non-alcoholic fatty liver disease and high BMI: a randomised, double-blind, placebo-controlled phase 2a trial. Lancet Gastroenterol Hepatol. 2023.

SOURCE Rivus Pharmaceuticals

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Medtronic announces departure of Karen Parkhill, Chief Financial Officer

Financial by Comments are Disabled

DUBLIN, June 26, 2024 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced that Karen Parkhill will resign as executive vice president and chief financial officer to accept the role of chief financial officer for HP Inc.
“On behalf of our employees, our executive committee and our board of directors, I want to thank Karen for her leadership over the last eight years. I am personally grateful to Karen for her support through my transition to CEO, navigating the pandemic and delivering a new operating model for the company. We wish her all the best as she takes on the next chapter of her career,” said Geoff Martha, Medtronic chairman and chief executive officer. “Across the company, we’re building momentum with our innovation-driven growth strategy, and we remain focused and committed to delivering on our short- and longer-term financial objectives.”
“It has been a pleasure to serve Medtronic and our Mission for the last eight years,” said Parkhill. “I am grateful to have had the opportunity to lead the outstanding finance team at Medtronic, and I know they will continue to deliver on our commitments. I remain excited about the plans Medtronic has for the future, and most of all, the huge impact Medtronic technologies will have on the lives of patients around the world.”
The company is evaluating internal and external succession candidates. Parkhill will continue to serve as chief financial officer until her departure on August 2, and Gary Corona, senior vice president, Global Financial Planning and Analysis, will serve as interim chief financial officer upon her departure.
In addition, the company also reaffirmed guidance for its first quarter and full fiscal year 2025, as previously disclosed in its May 23, 2024, earnings press release and webcast.
About Medtronic Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across more than 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic, visit www.Medtronic.com and follow Medtronic on LinkedIn. 
Forward-looking statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including risks related to competitive factors, difficulties and delays inherent in the development, manufacturing, marketing and sale of medical products, government regulation, geopolitical conflicts, general economic conditions, and other risks and uncertainties described in the company’s periodic reports on file with the U.S. Securities and Exchange Commission including the most recent Annual Report on Form 10-K of the company. Medtronic does not undertake to update its forward-looking statements, including to reflect future events or circumstances.

Contacts:

Erika Winkels            
Ryan Weispfenning

Public Relations         
Investor Relations

+1 (763) 526-8478              
+1 (763) 505-4626

SOURCE Medtronic plc

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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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