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Haemonetics Launches Limited Market Release for New VASCADE MVP XL Vascular Closure Device

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BOSTON, June 18, 2024 /PRNewswire/ — Haemonetics Corporation (NYSE: HAE), a global medical technology company focused on delivering innovative solutions to drive better patient outcomes, has launched a limited market release of its new VASCADE MVP® XL mid-bore venous closure device. The VASCADE MVP XL system expands Haemonetics’ VASCADE® portfolio of vascular closure systems featuring an innovative collapsible disc technology and a proprietary resorbable collagen patch designed to promote rapid hemostasis.
Haemonetics’ current VASCADE portfolio includes the VASCADE system, designed for “small-bore” femoral arterial and venous closure with standard 5-6/7F procedural sheaths, and the VASCADE MVP® system, designed for “mid-bore” multi-access femoral venous closure with 6-12F procedural sheaths. The upsized VASCADE MVP XL system utilizes 58% more collagen and a larger disc than the current VASCADE MVP system, providing a robust closure solution for procedures requiring 10-12F sheaths (up to 15F in outer diameter) such as cryoablation and left atrial appendage closure for atrial fibrillation patients.
“With VASCADE MVP XL, Haemonetics continues to expand its presence and broaden its reach in the $2.7 billion total addressable market for vascular closure solutions,” said Stew Strong, President of Global Hospital at Haemonetics. “The introduction of VASCADE MVP XL underscores our commitment to innovation and improving patient care, as we enhance our range of vascular closure solutions to address increasing demand for catheter-based ablation technologies. We are enthusiastic about the initial launch of VASCADE MVP XL and anticipate a full market release later this year.”
The VASCADE MVP XL system earned pre-market approval from the U.S. Food and Drug Administration this spring. The limited market release follows the first procedure performed using VASCADE MVP XL by Dr. Tom McElderry, Section Chief, Electrophysiology and Co-Director Heart & Vascular Center at the University of Alabama at Birmingham.
About Haemonetics
Haemonetics (NYSE: HAE) is a global healthcare company dedicated to providing a suite of innovative medical products and solutions for customers, to help them improve patient care and reduce the cost of healthcare. Our technology addresses important medical markets: blood and plasma component collection, the surgical suite and hospital transfusion services. Haemonetics’ Global Hospital business provides a range of solutions to address the needs of hospitals, including Interventional Technologies for electrophysiology and interventional cardiology, and Blood Management Technologies that include diagnostics to help inform treatment decisions, technologies to help avoid unnecessary allogeneic transfusions and solutions to help optimize management of blood products. To learn more about Haemonetics, visit www.haemonetics.com.
Cautionary Statement Regarding Forward-Looking Information 
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements in this press release may include, without limitation, statements regarding plans and objectives of management for the operation of Haemonetics, including statements regarding potential benefits associated with the Vascade MVP XL vascular closure device and Haemonetics’ plans or objectives related to the commercialization of such product. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon Haemonetics’ current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, product quality; market acceptance; the effect of global economic and political conditions; and the impact of competitive products and pricing. These and other factors are identified and described in more detail in Haemonetics’ periodic reports and other filings with the U.S. Securities and Exchange Commission. Haemonetics does not undertake to update these forward-looking statements.

Investor Contacts:  

Olga Guyette, Vice President-Investor Relations & Treasury 
David Trenk, Manager-Investor Relations

(781) 356-9763
(203) 733-4987

[email protected] 
[email protected]

Media Contact:

Josh Gitelson, Senior Director-Global Communications

(781) 356-9776

[email protected]

SOURCE Haemonetics Corporation

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Elutia Announces FDA Clearance of EluPro®: The First Antibiotic-Eluting BioEnvelope Designed to Protect Patients with Implantable Cardiac Pacemakers and Defibrillators

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EluPro becomes the only drug-eluting biologic envelope to receive FDA clearance in the $600 million U.S. implantable electronic device protection market EluPro also granted clearance for indications beyond CIEDs, including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea SILVER SPRING, Md., June 17, 2024 (GLOBE NEWSWIRE) — Elutia Inc. (Nasdaq: ELUT) (“Elutia” or the “Company”), a pioneer in drug-eluting biomatrix products, today announced that its Antibiotic-Eluting BioEnvelope, EluPro® (referred to as CanGaroo®RM during development), has received clearance from the U.S. Food and Drug Administration (FDA). Specifically designed to prevent post-operative complications for devices such as pacemakers and defibrillators, EluPro incorporates powerful antibiotic therapy combined with advanced tissue engineering to create a BioEnvelope that over time regenerates into a protective pocket of the patient’s own tissue. Infection, migration, and skin erosion are some of the most frequently encountered complications of pacemaker surgery, occurring in up to five to seven percent of cases. These cause significant patient morbidity and mortality, increase the length of hospitalization, and can add more than $50,000 to healthcare costs per event. In development since 2019 and protected by intellectual property extending beyond 2032, EluPro is the only biologic offering in the $600 million U.S. implantable electronic device protection market. The Company also announced that EluPro was granted clearance for indications beyond the cardiac implantable electronic devices (CIEDs), including neurostimulators and neuromodulators used for pain management, epilepsy, incontinence, and sleep apnea. These additional markets, estimated to be $8 billion worldwide, have not previously been served by a drug-eluting biomatrix and present significant additional growth opportunities for EluPro. “When I implant a pacemaker or defibrillator, minimizing the risk of any future complications is crucial,” said Dr. Benjamin D’Souza, Associate Professor of Medicine at the University of Pennsylvania and Section Chief of Cardiac Electrophysiology at Penn Presbyterian Medical Center. “However, the body’s natural immunity can treat the device like a foreign object contributing to inflammation, causing device migration, potentially eroding through the skin, or sometimes causing a serious infection. Those are the specific problems EluPro was designed to solve. It combines the remodeling properties of regenerative medicine through extracellular matrix along with long-acting antibiotic delivery to create a healthy environment for every device implantation.” The EluPro BioEnvelope is constructed from reinforced layers of natural extracellular tissue matrix and designed to create a conforming envelope with optimal stability for implantable electronic devices. The walls of EluPro are embedded with powerful antibiotics rifampin and minocycline, engineered for extended delivery directly into the surgical site long after closure. This unique combination of drug and biomatrix supports the regeneration of a healthy, vascularized pocket from the patient’s own tissue, mitigating a long-term foreign body response. “Post-operative infection, migration and erosion can result in significant morbidity and mortality for patients receiving a pacemaker or defibrillator. That is why we developed the antibiotic-eluting BioEnvelope,” said Dr. Randy Mills, Elutia’s Chief Executive Officer. “While the approval of EluPro is a major value inflection for Elutia, we believe it is just the tip of the iceberg. We have created a platform to protect patients from the foreign body response that can inevitably develop with any long-term implantable device. We intend to rapidly extend our product offering to other indications as we fulfill our mission to humanize medicine so patients can thrive without compromise.” EluPro represents a significant opportunity in the $600 million U.S. implantable electronic device protection market, previously served by a single competitor. With over 600,000 devices implanted in the U.S. annually, EluPro addresses significant complications arising from these procedures. Elutia plans to launch EluPro into the CIED market nationwide in the second half of 2024 and is prioritizing adjacent markets in the neurostimulation and modulation space, where implantable medical devices result in high rates of addressable complications. About Elutia Elutia develops and commercializes drug-eluting biomatrix products to improve compatibility between medical devices and the patients who need them. With a growing population in need of implantable technologies, Elutia’s mission is humanizing medicine so patients can thrive without compromise. For more information, visit www.Elutia.com. Forward-Looking Statements This press release 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. Forward-looking statements can be identified by words such as “projects,” “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential,” “promise,” “opportunity” or similar references to future periods. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including any statements regarding EluPro’s potential future success in the CIED protection market or in device protection for other types of implantable devices, like neurostimulators or neuromodulators, and statements regarding market size. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to us. Such beliefs and assumptions may or may not prove to be correct. Additionally, such forward-looking statements are subject to a number of known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in the forward-looking statements, including, but not limited to the following: our ability to continue as a going concern; the risk of product liability claims and our ability to obtain or maintain adequate product liability insurance; our ability to defend against the various lawsuits related to our recalled FiberCel and other viable bone matrix products and avoid a material adverse financial consequence from those lawsuits; our ability to achieve or sustain profitability; our ability to enhance our products, expand our product indications and develop, acquire and commercialize additional product offerings; our dependence on our commercial partners and independent sales agents to generate a substantial portion of our net sales; our dependence on a limited number of third-party suppliers and manufacturers, which, in certain cases are exclusive suppliers for products essential to our business; our ability to successfully realize the anticipated benefits of the November 2023 sale of our Orthobiologics business; physician awareness of the distinctive characteristics, benefits, safety, clinical efficacy and cost-effectiveness of our products; the continued and future acceptance of our products by the medical community; our ability to compete against other companies, most of which have longer operating histories, more established products and/or greater resources than we do; pricing pressure as a result of cost-containment efforts of our customers, purchasing groups, third-party payors and governmental organizations could adversely affect our sales and profitability; and our ability to obtain, maintain and adequately protect our intellectual property rights; and other important factors which can be found in the “Risk Factors” section of Elutia’s public filings with the Securities and Exchange Commission (“SEC”), including Elutia’s Annual Report on Form 10-K for the year ended December 31, 2023, as such factors may be updated from time to time in Elutia’s other filings with the SEC, including Elutia’s Quarterly Reports on Form 10-Q, accessible on the SEC’s website at www.sec.gov and the Investor Relations page of Elutia’s website at https://investors.elutia.com. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. Any forward-looking statement made by Elutia in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, Elutia expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investors:Matt SteinbergFINN Partnersmatt.steinberg@finnpartners.com

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FDA clears Clario’s SpiroSphere® with wireless ECG, streamlining data collection in clinical trials

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With the FDA 510(k) clearance of the COR-12 wireless ECG device now integrated with the SpiroSphere®, sponsors can conduct comprehensive respiratory trials with cardiac safety ECG collection on one device.

Clario’s SpiroSphere® integration with the wireless COR-12 is now FDA 510(k) cleared, allowing for consecutive collection of spirometry and ECG data during a single site visit.
The flexibility of the wireless COR-12 ECG enables integrated respiratory and cardiac safety trials for on-site, hybrid or remote trial design considerations.
The wireless feature of the SpiroSphere® ECG improves patient experience by removing the need for lead wires while maintaining high-quality data collection and accelerating trial timelines.

PHILADELPHIA, June 13, 2024 /PRNewswire/ — Clario, a leading provider of technologies and endpoint data solutions for clinical trials, today announced the U.S. Food and Drug Administration (FDA) 510(k) clearance for its SpiroSphere® with the wireless COR-12 Electrocardiogram (ECG) device. This technological advancement allows for the consecutive collection of spirometry and ECG data during a single site visit through Clario’s SpiroSphere® platform, consolidating all data into a single, unified database. This streamlines the clinical trial process and eliminates the need for separate ECG devices or multiple databases for a study.
Originally launched in 2018, the SpiroSphere®, a smart and lightweight pulmonary function testing (PFT) device, initially did not include ECG functionality. Now, the introduction of the SpiroSphere® ECG features the wireless COR-12 ECG device. This advancement enables customers to run integrated respiratory and cardiac safety trials on a single device and single database, simplifying the clinical trial process.
“The launch of our FDA-cleared SpiroSphere® wireless ECG device represents a significant step in improving clinical trial technology,” said Tom Stuckey, Senior Vice President, Respiratory & Precision Motion at Clario. “This clearance and product launch emphasizes our commitment to optimizing data collection, efficiency, and consistency, further enhancing how we deliver respiratory trials with cardiac safety.”
Ellen Street, Executive Vice President, Cardiac, Respiratory & Precision Motion at Clario added, “Our SpiroSphere® wireless ECG focuses on the site and patient experience while maintaining the high-quality data collection standards as our wired ECG model. With this wireless technology, site clinicians can now comfortably record both ECG and spirometry data in a single session on a single device, which can reduce the necessity for multiple devices, reduce burden, and accelerate trial timelines.”
This new product not only represents a technological advancement but also offers a cost-effective solution for enhanced efficiency and patient experience. For more information about the SpiroSphere® ECG and other Clario endpoint solutions, please visit Clario.com.
About ClarioClario is a leading healthcare research and technology company that generates high clinical evidence for our pharmaceutical, biotech, and medical device partners. We offer comprehensive evidence-generation solutions that combine eCOA, cardiac solutions, medical imaging, precision motion, and respiratory endpoints.
Since our founding more than 50 years ago, Clario has delivered deep scientific expertise and broad endpoint technologies to help transform lives around the world. Our endpoint data solutions have supported clinical trials over 26,000 times in more than 100 countries. Our global team of science, technology, and operational experts have supported over 60% of all FDA drug approvals since 2019.
For more information, go to Clario.com or follow us on LinkedIn.
Media Contact:Alexis NavratilCommunications Manager[email protected] 
SOURCE Clario

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Anthos Therapeutics Announces ~84% of Eligible Patients Have Transitioned to Abelacimab in the AZALEA-TIMI 71 Extension Study of Atrial Fibrillation Patients at a Moderate-to-High Risk of Stroke

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75% of patients in the rivaroxaban arm voluntarily switched from the once-daily oral anticoagulant to once-monthly abelacimab Landmark AZALEA-TIMI 71 Study previously stopped early due to an overwhelming benefit favoring abelacimab relative to rivaroxaban across all bleeding endpoints Data Monitoring Committee (DMC) recommended an open-label extension for all eligible patients to benefit from abelacimab treatment Abelacimab is a once-monthly, highly selective, fully human monoclonal antibody that achieves a near complete 99% inhibition of Factor XI CAMBRIDGE, Mass., June 06, 2024 (GLOBE NEWSWIRE) — Anthos Therapeutics, Inc., a clinical-stage company developing innovative therapies for cardiovascular diseases, founded by Blackstone Life Sciences (BXLS), today provided an update on the transition of patients in the open-label extension (OLE) portion of the AZALEA-TIMI 71 study. When the independent data monitoring committee (DMC) recommended that the study be stopped early because of the substantially greater than anticipated reduction in bleeding events favoring abelacimab over rivaroxaban, they also recommended that an optional open-label extension be made available so that all eligible patients could potentially benefit from abelacimab treatment. “The impressive bleeding reductions with abelacimab in the AZALEA-TIMI 71 study represent a potential game changer for how we treat patients with atrial fibrillation in the future, so it was no surprise when almost 84% of eligible patients, including the vast majority who had been on rivaroxaban during the trial, voluntarily decided to enter the open-label extension to receive abelacimab,” said Dr. Christian T. Ruff, MD, MPH, Principal Investigator of AZALEA-TIMI 71, the Director of General Cardiology at Brigham and Women’s Hospital, Senior Investigator of the TIMI Study Group, an Associate Member of the Broad Institute of MIT and Harvard, and an Associate Professor of Medicine at Harvard Medical School. The initial results of the AZALEA-TIMI 71 study1 of patients with atrial fibrillation at moderate-to-high risk of stroke were presented at the American Heart Association 2023 scientific congress during a late-breaking session. For the primary endpoint, abelacimab 150 mg dosed once-monthly, demonstrated a highly significant 67% reduction in major or clinically relevant non-major bleeding.1 In addition, there was a substantial 74% reduction in major bleeding alone and a 93% reduction in gastrointestinal (GI) bleeding, all favoring abelacimab over rivaroxaban, a standard-of-care anticoagulant.1 “We are very pleased that the open-label extension of the AZALEA-TIMI 71 study has completed its transition phase and that the vast majority of eligible patients voluntarily opted to receive abelacimab 150 mg once-monthly moving forward,” said Dr. Dan Bloomfield, Chief Medical Officer of Anthos Therapeutics. “Too many patients with diagnosed atrial fibrillation are not receiving an anticoagulant today or are taking an inappropriate dose, due to the risk or fear of bleeding, the possibility for drug-drug interactions, dosing complications due to age or renal status or just because they forget to take their daily medication. If approved, it is our hope that abelacimab will provide patients with the protection they need against blood clots, but with a placebo-like bleeding profile.” Atrial fibrillation, or AF, is the most common type of irregular heart rhythm. The most severe complication of AF is stroke,2 which can be prevented by taking an anticoagulant, or “blood thinner.” The Centers for Disease Control and Prevention (CDC) estimates that 12.1 million people in the United States will have atrial fibrillation by 2030.3 However, data from multiple patient registries and claims-based data analyses highlight that approximately 40% to 60% of patients with atrial fibrillation are either not on an anticoagulant or are receiving a sub-therapeutic dose and are thereby not benefiting from the protection that anticoagulants provide. This underuse of anticoagulants has been cited as one of the greatest public health issues facing cardiovascular patients.4 About Abelacimab Abelacimab is a highly selective, fully human monoclonal antibody that binds to FXI and locks it in the inactive state, preventing the formation of activated FXI (FXIa). As a monoclonal antibody, abelacimab is not metabolized via the cytochrome P450 system or as a substrate for P-glycoprotein, meaning the risk of drug-drug interactions is very low. There is no need to adjust the dose based on age or renal/hepatic status. Factor XI inhibition offers the promise of hemostasis-sparing anticoagulation for the prevention and treatment of arterial and venous thromboembolic events.5 Abelacimab is the only Factor XI inhibitor being studied for both conditions. In patients with atrial fibrillation, abelacimab is planned to be dosed subcutaneously (SC) monthly to maintain near-complete inhibition in a chronic setting. It is also planned to be administered via an initial intravenous (IV) infusion for acute indications requiring immediate onset of action and then followed by subsequent monthly SC administration. In the AZALEA-TIMI 71 study, abelacimab 150 mg dosed subcutaneously once-monthly, inhibited Factor XI by 99%.1 In a PK / PD study, abelacimab administered IV provided profound suppression of Factor XI within one hour after the start of therapy and maintained near maximal inhibition for up to 30 days.6 In a Phase 2 study published in the New England Journal of Medicine in 2021, a single intravenous dose of abelacimab after knee surgery reduced the rate of venous thromboembolism by 80%, measured 10 days after surgery, compared to enoxaparin.7 Abelacimab received a Fast Track Designation from the FDA in July 2022 for the treatment of thrombosis associated with cancer. In September 2022, abelacimab was also granted a Fast Track Designation for the prevention of stroke and systemic embolism in patients with atrial fibrillation. Abelacimab is an investigational agent and is not approved for any indication in any country. About the AZALEA-TIMI 71 Phase 2 Study The AZALEA-TIMI 71 study was an event-driven, randomized, active-controlled, blinded endpoint, parallel-group study with a primary endpoint that evaluated the effect of two blinded doses of abelacimab relative to open-label rivaroxaban in patients with atrial fibrillation (AF) who are at moderate-to-high risk of stroke. The primary endpoint of the AZALEA-TIMI 71 study was the composite of the rate of major or clinically relevant non-major bleeding events. A secondary endpoint was major bleeding on its own. Patients were randomized 1:1:1 and administered subcutaneous (SC) abelacimab 150 mg once-monthly, abelacimab 90 mg once-monthly, or rivaroxaban 20 mg daily. With a median follow-up of 21 months, spanning more than 2,000 patient-years, the AZALEA-TIMI 71 study is the largest and longest head-to-head study of a Factor XI inhibitor to provide definitive evidence of a highly significant reduction in bleeding as compared to a standard-of-care anticoagulant. Summary of Results as Presented During the American Heart Association 2023 Scientific Sessions:1 Primary endpoint met with a 67% reduction in major or clinically relevant non-major bleeding (CRNM) with abelacimab 150 mg compared with rivaroxaban 20 mg in patients with atrial fibrillation who are at moderate-to-high risk of stroke (P

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ACSD Granted Significant Telemedicine Patent

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IRVINE, Calif., June 5, 2024 /PRNewswire/ — ACS Diagnostics, Inc. of Irvine CA, with executive offices in Chattanooga TN, has been granted U.S Patent No. 11,980,452. The patent relates to ACSD’s Cardiac Monitoring CORE technology, specifically ambulatory ECG. The patented CORE device provides for multiple telemedicine related tests , including ECG/EKG, Holter, Event, and Mobile Cardiac Telemetry. The Core monitor integrates a cell phone module to alleviate the necessity for a companion phone for patient transmissions.
This is the fifth CORE technology patent, and relates to a single cardiac monitoring device offering to perform more than one of the above mentioned test modalities. The Core monitor is the only telemedicine device that is patented to offer the worldwide cardiology community all these tests within a one device. With this patent, the days of a provider needing to purchase a different monitor for each test are over.
This technology, and all related test modalities, are being successfully used by thousands of US customers, transmitting ECG patient data 24/7 to our California based IDTF laboratory. The ACSD IDTF laboratory is completely staffed with cardiac technicians to monitor patients and alert physicians to significant cardiac events.
A number of companies provide products for this market, including GE Healthcare, Medtronic, BioTelemetry / Philips, Boston Scientific, Samsung, Hill-Rom, IRhythm Technologies, Johnson & Johnson, OSI/Spacelabs, and a host of smaller players.
ACSD respects intellectual property rights and has a growing portfolio of patents, which are listed at www.ACSD4u.com/patents. ACSD firmly believes in innovation through research and development, and it will vigorously enforce its intellectual property rights.
SOURCE ACS Diagnsotics

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AliveCor’s AI-backed ECG Offerings Featured in New Film Series on Innovative Technologies Presented by the Consumer Technology Association

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The Human Component series, produced by BBC StoryWorks Commercial Productions, is now available to stream 
MOUNTAIN VIEW, Calif., June 5, 2024 /PRNewswire/ — AliveCor, the leading innovator in FDA-cleared personal electrocardiogram (ECG) technology, today announced its participation in The Human Component, a new online branded series developed for the Consumer Technology Association (CTA) and produced by BBC StoryWorks Commercial Productions, the commercial content division of BBC Studios.
The series showcases innovative technologies that are supporting healthier communities, stronger societies and a more resilient planet. Through compelling, human-led films, The Human Component celebrates global efforts to maximize the full potential of technology.
“We are incredibly proud to take part in The Human Component alongside innovators who are just as committed to introducing game-changing ideas to improve lives as we are,” said Priya Abani, CEO of AliveCor. “The series beautifully depicts the real-life impacts of technologies like our AI-backed ECG solutions and services, and how they are helping transform society for the better.”
AliveCor’s film shares the story of Dr. Cleveland Francis, a cardiologist and musician who was diagnosed with a heart condition after collapsing at home. After his episode, Dr. Francis used one of AliveCor’s FDA-cleared Kardia™ devices to take a real-time, clinical-grade ECG that he shared with his doctor, leading to a definitive diagnosis. Capable of remotely identifying six of the most common arrhythmias in just 30 seconds, Kardia personal ECGs place the power of advanced AI technology directly into users’ hands. They also offer healthcare providers a way to capture patients’ elusive arrhythmias, contributing to earlier diagnoses and improving clinical decision-making.
This is the second series that BBC StoryWorks has created for CTA, a trade association that brings together companies that improve lives through technology. By highlighting how innovators across industries are advancing groundbreaking new technologies, The Human Component explores how we can solve some of the most pressing challenges facing the world today.
To learn more, watch AliveCor’s full film at alivecor.com/cleveland-cardiology-ai.
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. 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.

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First Irish patient implanted with innovative heart failure management system from Irish Company FIRE1

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DUBLIN–(BUSINESS WIRE)–Dublin-based FIRE1 today announced that the first Irish patient has been successfully implanted with its FIRE1™ System for remote heart failure monitoring. The innovative system has the potential to positively impact thousands of people living with heart failure in Ireland every year and alleviate the burden on hospital emergency rooms. The […]

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Revolutionizing Oncology Care: AI-Powered Ultrasound Device Enhances Cardiac Monitoring for Chemotherapy Patients

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REDMOND, Wash., May 30, 2024 (GLOBE NEWSWIRE) — A recent study published in the European Heart Journal highlights the significant enhancements that the Kosmos ultrasound system, developed by EchoNous, brings to cardiac evaluations for chemotherapy patients. This AI-powered device enables even non-expert ultrasound users, such as junior oncologists and nurses, to accurately and swiftly assess left ventricular ejection fraction (LVEF), a crucial indicator of heart health and a critical measure to monitor in patients undergoing chemotherapy treatment. Dr. Dimitri Dionysopolous, one of the study’s authors, highlighted the Komsos’s significant impact: “With very little training, oncology staff can accurately measure a patient’s heart function in real-time. Our study revealed that the measurement process is very fast, taking less than 10 minutes from start to finish, which could dramatically change how we implement care in practice.” Kosmos, equipped with AI algorithms Trio and Kosmos Auto EF, guides users through the scanning process, making it easier to learn and enabling precise cardiac and abdominal imaging, along with more efficient LVEF calculations. This system, which produces high-quality echocardiographic images at the point of care, is a testament to the potential of AI in healthcare. “This is a tremendous result that fits into many conversations happening around healthcare right now,” said Graham Cox, CEO at EchoNous. “Healthcare organizations desperately need to enable less trained medical staff to perform ultrasound exams, and this study shows that it’s feasible with Kosmos and its AI capabilities.” In the study involving 115 patients, cardiologists performed traditional echocardiography and compared it with scans that oncology staff, including senior oncologists, residents, and nurses, performed using the Kosmos ultrasound system. The findings demonstrate that non-ultrasound experts can effectively use Kosmos, achieving diagnostic accuracy between 89 to 94 percent among different operators. These promising results suggest a future where Kosmos could be widely used by oncology staff, leading to faster clinical workflows and enhanced care for cancer patients. EchoNous will be showcasing the potential of Kosmos at the 2024 ASCO Annual Meeting from May 31 to June 4. Attendees are invited to visit our booth to learn more and chat with us. About EchoNous Headquartered in Redmond, Washington, EchoNous is a leader in creating innovative point-of-care ultrasound solutions. By combining premium ultrasound performance with cutting-edge AI educational tools, EchoNous expands the accessibility of advanced diagnostic capabilities, enabling more clinicians to obtain crucial patient information more swiftly. For further details, visit www.echonous.com. For further information, please contact: Luke BaldwinVP Global Marketing & Product ManagementLuke.Baldwin@EchoNous.com

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Kardium announces positive 1-year outcomes for PULSE-EU trial with the Globe® System, showing promise for improving the treatment of atrial fibrillation

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VANCOUVER, British Columbia–(BUSINESS WIRE)–Kardium Inc., a private medical device company that has developed the Globe® System for the treatment of atrial fibrillation (AF), announced positive results of the 1-year outcomes of the First-in-Human PULSE-EU Trial. These findings were presented as late-breaking clinical data at the Heart Rhythm Society (HRS) 2024 Annual Meeting […]

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Penn Presbyterian Medical Center Becomes First Hospital in the Northeast to Adopt Advanced Robotic Technology for Heart Treatment

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ST. LOUIS, May 29, 2024 (GLOBE NEWSWIRE) — Stereotaxis (NYSE: STXS), a pioneer in surgical robotics for minimally invasive endovascular intervention, today announces the successful treatment of the first heart rhythm patients by Penn Presbyterian Medical Center (PPMC) utilizing the advanced Genesis Robotic Magnetic Navigation System. PPMC, part of the University of Pennsylvania Health System, renowned for advanced clinical research, innovation, and compassionate patient care, stands at the forefront as the first in the Northeast United States to offer the Genesis System. Genesis is the latest advancement in Robotic Magnetic Navigation technology. Robotic Magnetic Navigation introduces the benefits of robotic precision and safety to cardiac ablation, a common minimally invasive procedure to treat arrhythmias. Tens of millions of individuals worldwide suffer from arrhythmias – abnormal heart rhythms that result when the heart beats too quickly, too slowly, or with an irregular pattern. When left untreated, arrhythmias may significantly increase the risk of stroke, heart failure, and sudden cardiac arrest. “Our adoption of advanced robotic technology significant enhances our ability to precisely diagnose and treat patients suffering from complex cardiac arrhythmias,” said Dr. Benjamin D’Souza, Cardiac Electrophysiologist at Penn Presbyterian Medical Center. “We are committed to leveraging cutting-edge innovations to provide patients with the best care. Our team has leveraged the precision and safety of robotics to treat patients that often have few other options for care. With unmatched accuracy, we can tailor treatments to each patient’s unique anatomy, enhancing safety and efficacy.” “We are excited to partner with Penn Presbyterian to pioneer the Genesis Robotic System in the Northeast,” said David Fischel, Chairman and CEO of Stereotaxis. “We look forward to supporting Penn Presbyterian in growing a highly successful and impactful robotic heart care program that advances patient care, clinical research and technology advancement.” About StereotaxisStereotaxis (NYSE: STXS) is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. These innovations help physicians provide unsurpassed patient care with robotic precision and safety, expand access to minimally invasive therapy, and enhance the productivity, connectivity, and intelligence in the operating room. Stereotaxis technology has been used to treat over 100,000 patients across the United States, Europe, Asia, and elsewhere. For more information, please visit www.stereotaxis.com This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to manage expenses at sustainable levels, acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its technology, competitive factors, changes resulting from healthcare policy, dependence upon third-party vendors, timing of regulatory approvals, the impact of pandemics or other disasters, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control and may be revised, modified, delayed, or canceled. Stereotaxis Contacts: David L. FischelChairman and Chief Executive Officer Kimberly PeeryChief Financial Officer 314-678-6100Investors@Stereotaxis.com

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