FDA Clears IND for Phase 3 Study of Cardiovascular Diagnostic Program</h1> <article> <h1>FDA Clears IND for Phase 3 Study of Cardiovascular Diagnostic Program</h1> <p>tim.hodson — Tue, 09 Jun 2026 22:51:06 +0000</p> <div class="field field--name-field-image field--type-image field--label-hidden field--items"> <div class="field--item"> <blockquote class="image-field-caption"><p>Photo: Getty Images</p> </blockquote> </div> </div> <span><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span>Tue, 06/09/2026 - 17:51</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>June 9, 2026.— <a href="https://www.pentixapharm.com/">Pentixapharm Holding AG</a> has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for its lead CXCR4-targeted diagnostic program in treatment resistant hypertension with underlying Primary Aldosteronism.</p> <p>With the IND now in effect, Pentixapharm is authorized to initiate its U.S.-focused, multi-center Phase 3 PANDA clinical study evaluating its novel imaging approach for patient stratification in hypertension, addressing a significant and underdiagnosed segment within endocrine/cardiovascular disease and representing a key near-term value driver for the company.</p> <h4>Phase 3 PANDA Study</h4> <p>The Phase 3 PANDA study has been designed based on prior interactions with the FDA, including formal feedback received in a Type B pre-IND meeting, which provided guidance on key statistical and methodological aspects as well as evidence requirements toward a potential approval pathway. The IND clearance confirms alignment with the FDA on the proposed study design and supports a registrational development strategy.</p> <p>Pentixapharm's CXCR4-targeted imaging platform represents a first-in-class approach in cardiovascular diagnostics, enabling non-invasive assessment of disease biology and supporting more precise treatment decisions in hypertensive patients. The program addresses a major unmet need in a large and rapidly evolving cardiovascular market, with the potential to improve diagnostic pathways and enable more targeted therapeutic intervention.</p> <p>"This IND clearance represents a key execution milestone and confirms our ability to deliver on our regulatory strategy," said Dirk Pleimes, Chief Executive Officer of Pentixapharm. "With our flagship PANDA program now advancing into Phase 3 in the United States, we are entering the next phase of value creation. Primary aldosteronism affects up to 10% of patients with hypertension, yet remains significantly underdiagnosed. We believe our first-in-class PET/CT imaging approach has the potential to transform how these patients are identified and, importantly, to guide treatment decisions by enabling precise subtype differentiation. We are focused on rapid study initiation and disciplined execution, while actively engaging with potential strategic partners across imaging and cardiovascular therapeutics. In parallel, we are advancing financing initiatives to support Phase 3 execution and our continued expansion in the U.S. market."</p> <p>"The Phase 3 IND clearance is a critical milestone confirming that [⁶⁸Ga]Ga-PentixaFor has reached the technological maturity required for pivotal clinical execution," said Erik Merten, Chief Technology Officer of Pentixapharm. "We have established a robust and scalable manufacturing and supply infrastructure and are well positioned to ensure reliable supply as we initiate the Phase 3 program and progress toward potential commercialization."</p> <p><b> </b></p> <p></p><p> </p> </div> <span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="http://www.dicardiology.com/content/fda-clears-ind-phase-3-study-cardiovascular-diagnostic-program" data-a2a-title="FDA Clears IND for Phase 3 Study of Cardiovascular Diagnostic Program"><hr /><h4 class="share-title">If you enjoy this content, please share it with a colleague</h4><a class="a2a_button_email"></a><a class="a2a_button_facebook"></a><a class="a2a_button_twitter"></a><a class="a2a_button_linkedin"></a><a class="a2a_dd addtoany_share" href="https://www.addtoany.com/share#url=http%3A%2F%2Fwww.dicardiology.com%2Fcontent%2Ffda-clears-ind-phase-3-study-cardiovascular-diagnostic-program&title=FDA%20Clears%20IND%20for%20Phase%203%20Study%20of%20Cardiovascular%20Diagnostic%20Program"></a></span> </article> <article> <h1>Novel Polymer-Based Coil Now Available from Embolization</h1> <p>tim.hodson — Mon, 08 Jun 2026 17:10:09 +0000</p> <div class="field field--name-field-image field--type-image field--label-hidden field--items"> <div class="field--item"> <blockquote class="image-field-caption"><p>Photo: Embolization, Inc.</p> </blockquote> </div> </div> <span><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span>Mon, 06/08/2026 - 12:10</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>June 8, 2026 <b>– </b><a href="https://embolizationinc.com/">Embolization, Inc.</a> will present its novel embolization coil, using proprietary shape-memory biocompatible polymers to treat peripheral vasculature at the <a href="https://vam.vascular.org/">Vascular Annual Meeting</a>, in Boston, Massachusetts.</p> <p>Embolization will be highlighting its NED coil. Intended for arterial and venous embolization in peripheral vasculature, the novel, polymer-based device minimizes artifacts in CT and MRI imaging that occur with traditional metal devices, according to Jim Kasic, Embolization's CEO.</p> <p>The NED, which has obtained FDA 501(k) clearance, is the only polymer-based coil on the market; all others are metal-based. The coils, Kasic says, remain radiopaque under fluoroscopy even though the CT/MRI imaging artifact is minimal.</p> <p>Kasic says that initial results show shorter occlusion times and tighter coil packs, which can result in fewer devices per procedure, lower recanalization rates and lower manufacturing costs. “The NED coil does everything a traditional metal coil does, but with a novel, radiopaque polymer.”</p> <p>NED is demonstrating success in its limited-market release, with use cases topping 70 coils in 11 cases. In all cases, across four institutions and physicians, the NED has shown consistent performance in venous and arterial applications.</p> <p>“The opportunity to talk with experts at VAM, the premier source of education for vascular health professionals, is an opportunity to share what I believe represents the next generation in embolic coils,” says Kasic.</p> <p>Embolization, Inc., based in Boulder, Colorado, specializes in the development of minimally invasive medical devices for peripheral vascular and neurovascular uses.</p> <p> </p> <p></p><p> </p> </div> <span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="http://www.dicardiology.com/content/novel-polymer-based-coil-now-available-embolization" data-a2a-title="Novel Polymer-Based Coil Now Available from Embolization"><hr /><h4 class="share-title">If you enjoy this content, please share it with a colleague</h4><a class="a2a_button_email"></a><a class="a2a_button_facebook"></a><a class="a2a_button_twitter"></a><a class="a2a_button_linkedin"></a><a class="a2a_dd addtoany_share" href="https://www.addtoany.com/share#url=http%3A%2F%2Fwww.dicardiology.com%2Fcontent%2Fnovel-polymer-based-coil-now-available-embolization&title=Novel%20Polymer-Based%20Coil%20Now%20Available%20from%20Embolization"></a></span> </article> <article> <h1>HeartSciences Launches New Version of MyoVista Insights with AI-ECG</h1> <p>tim.hodson — Fri, 05 Jun 2026 17:45:30 +0000</p> <div class="field field--name-field-image field--type-image field--label-hidden field--items"> <div class="field--item"> </div> </div> <span><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span>Fri, 06/05/2026 - 12:45</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>June 2, 2026 —<a href="http://www.heartsciences.com.">HeartSciences Inc.</a> has announced the commercial release of MyoVista Insights version 1.3, a major platform update that introduces the MyoVista Insights AI-ECG Algorithm Marketplace. The Marketplace enables third-party algorithm results to be integrated into the MyoVista Insights platform, beginning with an FDA-cleared AI-ECG model from <a href="https://www.bunkerhillhealth.com/">Bunkerhill Health</a>. The Bunkerhill ECG-EF model enables clinicians to detect reduced left ventricular ejection fraction (LVEF ≤40%) from a routine 12-lead ECG.</p> <p>The marks the first time a cleared AI-ECG algorithm is available through MyoVista Insights, making the ECG-EF algorithm accessible to healthcare facilities of every size, from large integrated health systems to community hospitals, critical access hospitals, and primary care practices across the United States. It also establishes the platform as a commercial pathway for AI-ECG developers seeking to reach clinical users through a recurring, SaaS-based revenue model, without the cost or complexity, of building their own end-to-end workflow and distribution infrastructure. HeartSciences is in active discussions to add further third-party owned and cleared algorithms and expects the marketplace to expand over the coming quarters.</p> <p>Andrew Simpson, CEO, HeartSciences, said, “We are now delivering a cleared AI-ECG algorithm into clinical workflows through MyoVista Insights, with a recurring, SaaS-based revenue model that we believe can create meaningful and scalable value for the Company. Bunkerhill’s ECG-EF algorithm is the first of what we expect to be many. We are in active discussions with additional algorithm developers who recognize that delivering algorithms into clinical practice, not simply developing them, is the critical step, and we believe MyoVista Insights is uniquely positioned to be that delivery platform for institutions of every size.”</p> <h4>AI-ECG Algorithms</h4> <p>Detection of reduced LVEF from a routine ECG supports earlier identification and is expected to result in more effective referral of patients at risk of heart failure. Assessments performed with assistive AI-ECG algorithms are eligible for Medicare reimbursement under the Hospital Outpatient Prospective Payment System, assigned to Ambulatory Payment Classification (APC) 5734 at a national payment rate of approximately $136 per assessment for 2026. With AI-ECG forecast to become a multi-billion-dollar market, HeartSciences believes an established reimbursement pathway, combined with its recurring SaaS-based revenue model, positions the Company to capture meaningful and scalable revenue as adoption grows and additional algorithms are added to the platform.</p> <p>Nishith Khandwala, co-founder and CEO, Bunkerhill Health, added, “This collaboration gives more health systems a pathway to adopt our FDA-cleared ECG-EF algorithm and to use routine ECG data to support earlier evaluation and more informed clinical decisions for patients at risk of heart failure.”</p> <p>MyoVista Insights is a cloud-native, next-generation ECG management system designed to be device-agnostic that delivers workflow efficiency and third-party, FDA-cleared AI results directly into clinical practice. Because it is cloud-based, cost-effective, and independent of any single manufacturer’s hardware, the platform gives institutions of every size a unified environment for deploying cleared AI-ECG algorithms within routine clinical workflows. MyoVista Insights holds Epic Toolbox designation for the ECG Management System category and supports integration with electronic health records through HL7v2 order and results workflows, single sign-on (SSO), and SMART on FHIR.</p> <p> </p> <p></p><p> </p> </div> <span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="http://www.dicardiology.com/content/heartsciences-launches-new-version-myovista-insights-ai-ecg" data-a2a-title="HeartSciences Launches New Version of MyoVista Insights with AI-ECG"><hr /><h4 class="share-title">If you enjoy this content, please share it with a colleague</h4><a class="a2a_button_email"></a><a class="a2a_button_facebook"></a><a class="a2a_button_twitter"></a><a class="a2a_button_linkedin"></a><a class="a2a_dd addtoany_share" href="https://www.addtoany.com/share#url=http%3A%2F%2Fwww.dicardiology.com%2Fcontent%2Fheartsciences-launches-new-version-myovista-insights-ai-ecg&title=HeartSciences%20Launches%20New%20Version%20of%20%20MyoVista%20Insights%20with%20AI-ECG"></a></span> </article> <article> <h1>Robocath Completes Enrollment in First-In-Human Study of Next-Gen Robotic Platform</h1> <p>tim.hodson — Thu, 04 Jun 2026 14:41:09 +0000</p> <div class="field field--name-field-image field--type-image field--label-hidden field--items"> <div class="field--item"> <blockquote class="image-field-caption"><p>Dr. Mohammed Nejjari (pictured above) alongside<br /> Dr. Franck Digne conducted the study at the<br /> Centre Cardiologique du Nord (CCN) in<br /> Saint-Denis, France. (Photo: Robocath)</p> </blockquote> </div> </div> <span><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span>Thu, 06/04/2026 - 09:41</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>May 11, 2026 — In May, <a href="http://www.robocath.com">Robocath</a> announced the completion of patient enrollment in the FIH (First-In-Human) clinical study evaluating its next-generation robotic system for percutaneous coronary interventions (PCI).</p> <p>Conducted at the <a href="http://www.ccn.fr">Centre Cardiologique du Nord</a> (CCN) in Saint-Denis, France, and led by Dr. Mohammed Nejjari, principal investigator, alongside Dr. Franck Digne, the study assessed the feasibility and safety of Robot-Assisted Percutaneous Coronary Intervention (RA-PCI) using Robocath’s next-generation system in patients with coronary artery disease.</p> <p>"Completing enrollment in this First-In-Human study is a defining moment in the field of interventional cardiology,” said Dr. Mohammed Nejjari. “For the first time, we have demonstrated that robotic assistance can be safely and reliably applied to the full spectrum of coronary lesion complexity, including the most challenging anatomies. This is not a glimpse into the future: it is the future, starting now."</p> <h4>Second Generation Robotic Platform</h4> <p>Robocath’s second-generation robot leverages the clinical and technological experience from its first robotic platform, now used in centers worldwide, and integrates advanced capabilities such as multi-device handling to support increasingly complex coronary procedures.</p> <p>The study included 20 patients (≥ 18 years old) with coronary artery disease, primarily complex cases seen in real-world catheterization laboratory practice. They were stratified by coronary lesion complexity across three subgroups:</p> <ul type="disc"><li>Type A/B1 lesions: 6 patients</li> <li>Type B2 lesions: 7 patients</li> <li>Type C lesions: 7 patients</li> </ul><p>To date, no safety concerns have been reported in connection with the use of Robocath’s system. Technical outcomes observed across all lesion subgroups - including complex Type B2 and Type C anatomies - are considered promising.</p> <p>“Congratulations to Dr. Mohammed Nejjari and the CCN team for completing full-patient enrollment in this study, a worldwide first-of-its-kind achievement,” said Philippe Bencteux, CEO of Robocath. “This is a key milestone in validating our unique technology, designed to transform PCI management across all levels of complexity. We remain committed to advancing coronary artery disease care, the world’s leading cause of death, while improving the daily practice of healthcare professionals.”</p> <p>These early findings support the potential of Robocath’s next-generation system to address a broad spectrum of coronary artery disease presentations, including patients with challenging anatomical characteristics. Full data analysis and detailed results will be presented in the near-term in forthcoming scientific communications.</p> <p>The global vascular interventional robot market was valued at $61.1 million in 2024. This is <a href="https://www.intelmarketresearch.com/vascular-interventional-robot-market-9928">projected to grow</a> from $78.3 million in 2025 to $297 million by 2031, exhibiting a CAGR of 26% during the forecast period. The market growth is driven by increasing demand for minimally invasive surgeries, technological advancements in robotic systems and the rising prevalence of cardiovascular diseases, further strengthening Robocath’s market positioning.</p> <p> </p> <p></p><p> </p> </div> <span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="http://www.dicardiology.com/content/robocath-completes-enrollment-first-human-study-next-gen-robotic-platform" data-a2a-title="Robocath Completes Enrollment in First-In-Human Study of Next-Gen Robotic Platform "><hr /><h4 class="share-title">If you enjoy this content, please share it with a colleague</h4><a class="a2a_button_email"></a><a class="a2a_button_facebook"></a><a class="a2a_button_twitter"></a><a class="a2a_button_linkedin"></a><a class="a2a_dd addtoany_share" href="https://www.addtoany.com/share#url=http%3A%2F%2Fwww.dicardiology.com%2Fcontent%2Frobocath-completes-enrollment-first-human-study-next-gen-robotic-platform&title=Robocath%20Completes%20Enrollment%20in%20First-In-Human%20Study%20of%20Next-Gen%C2%A0Robotic%20Platform%20"></a></span> </article> <article> <h1>FDA Clears Clarius Ejection Fraction AI to Deliver Objective, Real-Time Cardiac Ultrasound Assessments</h1> <p>tim.hodson — Wed, 03 Jun 2026 16:04:35 +0000</p> <div class="field field--name-field-image field--type-image field--label-hidden field--items"> <div class="field--item"> <blockquote class="image-field-caption"><p>Clarius Ejection Fraction AI is a new cardiac ultrasound tool<br /> for real-time cardiac assessments. (Photo: Clarius Mobile Health)</p> </blockquote> </div> </div> <span><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span>Wed, 06/03/2026 - 11:04</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>June 2, 2026 — Clarius Mobile Health has announced the availability of its new <a href="https://l.clarius.com/ef-ai">Ejection Fraction (EF) AI</a>, which has been cleared for use by the United States Federal Department of Food and Drug Administration (FDA). This intelligent cardiac assessment tool is integrated directly into the Clarius Ultrasound App to provide clinicians with an automated, objective measurement of left ventricular function — the percentage of blood the heart pumps out with each beat.</p> <p>Assessing left ventricular (LV) systolic function is critical, yet traditional methods often rely on subjective visual estimation, which is highly operator dependent. Clarius Ejection Fraction AI automatically calculates and displays the EF percentage in real-time from standard cardiac windows. It was developed using thousands of cardiac ultrasound images annotated by clinicians to support consistent left ventricle ejection fraction assessment.</p> <p>"Quantifying cardiac function has historically required a high level of sonography expertise or a wait for formal echocardiography," says Clarius Vice President of Marketing, Sarah Leverett. "By integrating Ejection Fraction AI into our wireless scanners, we are providing an objective anchor for clinicians. This tool allows them to move from a subjective guess to a data-driven diagnosis in seconds."</p> <p>The clinical impact is evident for physicians working in high-pressure environments. "The ability to receive a calculated EF just from a parasternal long or 4 chamber view is magical," says Dr. Brian Johnson, an Emergency Physician who was one of the first to test <a href="https://l.clarius.com/ef-ai">Clarius Ejection Fraction AI</a>.</p> <p>Clarius Ejection Fraction AI is available now in the United States and other countries to users of the Clarius <a href="https://store.clarius.com/?utm_source=prnewswire.com&utm_medium=referral">PA</a>, <a href="https://store.clarius.com/?utm_source=prnewswire.com&utm_medium=referral">PAL</a> and <a href="https://store.clarius.com/?utm_source=prnewswire.com&utm_medium=referral">C3 </a>HD3 wireless ultrasound scanners via the latest app update. Access to all Clarius Intelligence tools is open to users with access to Clarius Membership and One-Time Licenses.</p> <h4><b>Key Benefits of Ejection Fraction AI:</b></h4> <ul type="disc"><li> <p><b>Removes Subjectivity:</b> Automatically calculates and documents ejection fraction percentage based on cardiac ultrasound images without requiring user intervention.</p> </li> <li> <p><b>Accelerates Diagnosis:</b> Provides high-accuracy EF results across a range of patient body types and image qualities.</p> </li> <li> <p><b>Seamless Workflow:</b> Integrates directly into the Clarius App, requiring minimal steps from probe-on-patient to result.</p> </li> <li> <p><b>Improves Access:</b> Enables cardiac monitoring in rural or underserved communities where formal echocardiography wait times are often prohibitive.</p> </li> </ul><p><b>Bridging the Gap</b></p> <p>The American Academy of Family Physicians (AAFP) recently recognized cardiac POCUS as a core clinical competency. However, many primary care physicians lack the specialized training to accurately interpret LV function. Ejection Fraction AI provides these clinicians with a longitudinal marker of disease progression.</p> <p>By identifying a decline in EF before a patient reaches a crisis point, such as a drop below 40%, indicating possible heart failure, physicians can trigger guideline-directed medical therapy and informed specialist referrals earlier.</p> <p><b>Speed and Precision</b></p> <p>In emergency and critical care settings, where time is the most critical variable, Ejection Fraction AI delivers actionable information within the 90-second window required for resuscitation guidance. The ultrasound tool assists in evaluating undifferentiated shortness of breath, septic shock, and trauma, ensuring that fluid resuscitation and medication initiation are based on precise, real-time cardiac data.</p> <p> </p> <p></p><p> </p> </div> <span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="http://www.dicardiology.com/content/fda-clears-clarius-ejection-fraction-ai-deliver-objective-real-time-cardiac-ultrasound" data-a2a-title="FDA Clears Clarius Ejection Fraction AI to Deliver Objective, Real-Time Cardiac Ultrasound Assessments"><hr /><h4 class="share-title">If you enjoy this content, please share it with a colleague</h4><a class="a2a_button_email"></a><a class="a2a_button_facebook"></a><a class="a2a_button_twitter"></a><a class="a2a_button_linkedin"></a><a class="a2a_dd addtoany_share" href="https://www.addtoany.com/share#url=http%3A%2F%2Fwww.dicardiology.com%2Fcontent%2Ffda-clears-clarius-ejection-fraction-ai-deliver-objective-real-time-cardiac-ultrasound&title=FDA%20Clears%20Clarius%20Ejection%20Fraction%20AI%20to%20Deliver%20Objective%2C%20Real-Time%20Cardiac%20Ultrasound%20Assessments"></a></span> </article> <article> <h1>Medtronic Invests in Intracardiac Echocardiography Technologies</h1> <p>tim.hodson — Wed, 03 Jun 2026 14:46:43 +0000</p> <div class="field field--name-field-image field--type-image field--label-hidden field--items"> <div class="field--item"> </div> </div> <span><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span>Wed, 06/03/2026 - 09:46</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>June 3, 2026 — <a href="http://Medtronic.com">Medtronic </a>has announced strategic investments in two privately held companies focused on the development of intracardiac echocardiography (ICE) catheter technologies. ICE catheters provide real-time, high-resolution imaging of the heart during electrophysiology (EP) procedures for cardiac arrhythmias such as atrial fibrillation (Afib). Medtronic intends to integrate ICE into the Affera mapping and ablation system to continue building on the differentiated value proposition of the Affera ecosystem.</p> <p>The investments further reinforce the momentum of the cardiac ablation business at Medtronic and include Beluga Medical, a premarket-stage company located in California developing a next-generation ICE product, and CardioACC, an early commercial-stage company based in Shenzhen, China. CardioACC received National Medical Products Administration approval for its ICE system in 2025.</p> <p>"The incredible growth of our business demonstrates the demand for better technologies in electrophysiology, and we are leaning into opportunities that support our long-term portfolio roadmap," said Rebecca Seidel, president of the Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio. "ICE catheters are an important component of ablation procedures today, and we intend for our Affera platform to evolve to include this capability. These investments represent another step to support expansion of our leadership position in EP as we work to bring new and innovative technologies to each market."</p> <h4>Investing in Intracardiac Echocardiography</h4> <p>The investments in cardiac ablation continue the recent cadence of strategic transactions at Medtronic to strengthen the company's leadership within its core franchises. Medtronic continues to prioritize high-growth opportunities to complement its core businesses and deliver sustained value for physicians and hospital partners.</p> <p>"Intracardiac echocardiography has become a procedural essential in electrophysiology, giving physicians real-time visualization that can support more confident decision making throughout an ablation case," said Khaldoun Tarakji, M.D., MPH, vice president, chief medical officer, Cardiac Ablation Solutions business, which is part of the Cardiovascular Portfolio at Medtronic. "By investing in ICE technologies, we are strategically positioning ourselves to evolve and strengthen the Affera ecosystem over time, with the goal of continuing to advance integrated imaging and mapping workflows, improve procedural efficiency, and deliver better outcomes for patients."</p> <p>Both ICE catheter companies will continue to operate independently.</p> <p> </p> <p></p> </div> <span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="http://www.dicardiology.com/content/medtronic-invests-intracardiac-echocardiography-technologies" data-a2a-title="Medtronic Invests in Intracardiac Echocardiography Technologies"><hr /><h4 class="share-title">If you enjoy this content, please share it with a colleague</h4><a class="a2a_button_email"></a><a class="a2a_button_facebook"></a><a class="a2a_button_twitter"></a><a class="a2a_button_linkedin"></a><a class="a2a_dd addtoany_share" href="https://www.addtoany.com/share#url=http%3A%2F%2Fwww.dicardiology.com%2Fcontent%2Fmedtronic-invests-intracardiac-echocardiography-technologies&title=Medtronic%20Invests%20in%20Intracardiac%20Echocardiography%20Technologies"></a></span> </article> <article> <h1>AccurKardia Receives Patent for AI-Driven ECG Detection of Cardiac Amyloidosis</h1> <p>tim.hodson — Tue, 02 Jun 2026 16:10:33 +0000</p> <div class="field field--name-field-image field--type-image field--label-hidden field--items"> <div class="field--item"> </div> </div> <span><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span>Tue, 06/02/2026 - 11:10</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>June 2, 2026 — <a href="https://www.accurkardia.com/">AccurKardia, Inc.</a> has been granted US Patent No. 12,620,488 for the company's proprietary machine-learning-based system for identifying cardiac amyloidosis from a standard, routinely performed 12-lead ECG.</p> <p>Cardiac amyloidosis is a serious, often fatal heart disease in which abnormal proteins build up in heart tissue, causing the heart muscle to stiffen and eventually fail. Only recently recognized as a leading cause of heart failure in older adults, the condition remains widely underdiagnosed. Most patients are identified only after permanent damage to the heart has already occurred. The stakes of earlier detection are high and concrete: it impacts which treatments patients receive and how long they live. In heart failure clinics, studies estimate that roughly 13-15 percent of patients have undiagnosed cardiac amyloidosis.<sup>i</sup> Catching it sooner steers patients away from standard heart failure treatments that may be ineffective or even harmful for this condition, and toward therapies proven to improve survival.</p> <p>"Cardiac amyloidosis hides in plain sight, and because the symptoms are quite similar to other causes of heart failure, we have historically relied on expensive, late-stage imaging to diagnose what is already advanced disease, often after conventional medical therapy has failed to improve symptoms," said Dr. Jason Lazar, executive vice dean, chair of the Department of Medical Education and Director of Non-invasive Cardiology at SUNY Downstate. “A reliable ECG-based screening signal, leveraging information the human eye simply cannot extract, has the potential to redefine when and how we intervene, particularly as therapeutic options continue to expand. Simply put, earlier diagnosis leads to much better outcomes.”</p> <h4>AccurKardia's Approach</h4> <p>AccurKardia’s patent establishes its intellectual property foundation across all major amyloidosis subtypes, including AL amyloidosis and wild-type and hereditary ATTR amyloidosis. It joins a growing pipeline of AccurKardia AI-ECG biomarkers that includes FDA Breakthrough Device-designated algorithms for aortic stenosis (AK-AVS™) and hyperkalemia (AK+ Guard), alongside the company's FDA-cleared automated ECG interpretation platform, AccurECG 2.0.</p> <p>"Disease-modifying amyloidosis therapies are among the most important advances in cardiology in a generation, but their impact is gated by our ability to find the right patients in time," said Juan C. Jimenez, co-Founder and CEO of AccurKardia. "This patent establishes the foundation for closing that gap. We are turning a test that is already performed millions of times per year globally into a screening biomarker, deployable without new hardware or procedures, seamlessly integrating our capabilities into existing workflows."</p> <p>A distinguishing feature of AccurKardia's approach is its use of explainable, feature-based machine learning, built on annotated ECG parameters, rather than a “black box” model. The design supports interpretability for clinicians, transparency for regulators, and adaptability for downstream deployment at scale.</p> <p><sup>i</sup> See, ASY, Ho, JS, Chan, MY, et. al. Prevalence and Risk Factors of Cardiac Amyloidosis in Heart Failure: A Systematic Review and Meta-Analysis. Heart Lung Circ. 2022 Nov;31(11):1450-1462. doi: 10.1016/j.hlc.2022.08.002. Epub 2022 Sep 20. PMID: 36137915.</p> <p> </p> <p></p><p> </p> </div> <span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="http://www.dicardiology.com/content/accurkardia-receives-patent-ai-driven-ecg-detection-cardiac-amyloidosis" data-a2a-title="AccurKardia Receives Patent for AI-Driven ECG Detection of Cardiac Amyloidosis"><hr /><h4 class="share-title">If you enjoy this content, please share it with a colleague</h4><a class="a2a_button_email"></a><a class="a2a_button_facebook"></a><a class="a2a_button_twitter"></a><a class="a2a_button_linkedin"></a><a class="a2a_dd addtoany_share" href="https://www.addtoany.com/share#url=http%3A%2F%2Fwww.dicardiology.com%2Fcontent%2Faccurkardia-receives-patent-ai-driven-ecg-detection-cardiac-amyloidosis&title=AccurKardia%20Receives%20Patent%20for%20AI-Driven%20ECG%20Detection%20of%20Cardiac%20Amyloidosis"></a></span> </article> <article> <h1>Redefining PE and VTE Intervention</h1> <p>tim.hodson — Mon, 01 Jun 2026 14:10:06 +0000</p> <span rel="sioc:has_creator"><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span property="dc:date dc:created" content="2026-06-01T14:10:06+00:00" datatype="xsd:dateTime">Mon, 06/01/2026 - 09:10</span> </article> <article> <h1>RWJBarnabas Health Earns ACC Cardiac Cath Lab Recognition</h1> <p>tim.hodson — Fri, 29 May 2026 14:43:34 +0000</p> <div class="field field--name-field-image field--type-image field--label-hidden field--items"> <div class="field--item"> </div> </div> <span><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span>Fri, 05/29/2026 - 09:43</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>May 28, 2026 — <a href="http://www.RWJBH.org">RWJBarnabas Health</a> has earned Cardiac Catheterization Lab Accreditation from the <a href="http://acc.org">American College of Cardiology (ACC) </a>in recognition of the health system’s excellence and consistency in delivering heart care. </p> <p>This designation follows an onsite evaluation of the staff’s ability to evaluate, diagnose and treat patients in each of the 11 cardiac catheterization labs across RWJBarnabas Health. The accreditation confirms RWJBarnabas Health’s successful implementation of standardized, evidence‑based practices across all hospital locations, reducing variation in care and ensuring that patients receive the same high‑quality treatment no matter which cardiac catheterization lab they visit across the system. </p> <p>“Achieving system‑wide ACC accreditation underscores our commitment to delivering high‑quality cardiac care to every community we serve across the entire state of New Jersey,” said Conor Barrett, MD, MBA, Chief Clinical Officer, RWJBarnabas Health Heart & Vascular. “This coordinated effort sets RWJBarnabas Health apart as New Jersey’s premier destination for heart care.” </p> <p>Accredited hospitals must meet strict criteria for patient assessment, safety protocols, procedure‑room coordination and recovery‑unit communication. These standards improve patient safety, streamline care and enhance outcomes for individuals experiencing heart conditions. </p> <p>“RWJBarnabas Health has demonstrated its commitment to providing New Jersey with excellent heart care,” said Deepak L. Bhatt, MD, MPH, FACC, chair of the ACC Accreditation Management Board. “ACC Accreditation Services is proud to award RWJBarnabas Health’s 11 participating hospitals with cardiac catheterization centers with Cardiac Catheterization Lab Accreditation.”</p> <h4>Accredited RWJBarnabas Health Hospitals</h4> <p>The RWJBarnabas Health hospitals that achieved ACC Cardiac Catheterization Lab Accreditation are:</p> <ul><li> <p>Clara Maass Medical Center in Belleville, Community Medical Center in Toms River,</p> </li> <li> <p>Cooperman Barnabas Medical Center in Livingston,</p> </li> <li> <p>Jersey City Medical Center in Jersey City,</p> </li> <li> <p>Monmouth Medical Center in Long Branch,</p> </li> <li> <p>Newark Beth Israel Medical Center in Newark,</p> </li> <li> <p>Robert Wood Johnson University Hospital New Brunswick,</p> </li> <li> <p>Robert Wood Johnson University Hospital Rahway in Hamilton,</p> </li> <li> <p>Robert Wood Johnson University Hospital Rahway,</p> </li> <li> <p>Robert Wood Johnson University Hospital Somerset in Somerville,</p> </li> <li> <p>Trinitas Regional Medical Center in Elizabeth.</p> </li> </ul><p> ACC Accreditation Services provides U.S. and international hospitals, including RWJBarnabas Health, with a comprehensive portfolio of cardiac accreditation programs designed to advance quality, strengthen operational performance and support better patient outcomes. The services span the full continuum of cardiac care, including cardiac catheterization laboratories. </p> <p>RWJBarnabas Health Heart & Vascular represents New Jersey’s most comprehensive academic network for cardiac and vascular care<strong>, </strong>uniting the state’s leading cardiologists, surgeons, and specialists across an expansive outpatient footprint and 12 hospitals. RWJBarnabas Health Heart & Vascular national distinctions include a heart transplant program among the nation’s top 15, delivering life‑saving innovation and exceptional outcomes; New Jersey’s only Joint Commission Comprehensive Cardiac Center located at Robert Wood Johnson University Hospital, underscoring the highest standards of coordinated, advanced cardiac care; and the state’s largest volume minimally-invasive structural heart program, powered by four high-volume cardiac surgery centers at Cooperman Barnabas Medical Center, Jersey City Medical Center, Newark Beth Israel Medical Center and Robert Wood Johnson University Hospital.</p> <p>The ACC offers U.S. and international hospitals like RWJBarnabas Health access to a comprehensive suite of cardiac accreditation services designed to optimize patient outcomes and improve hospital financial performance. These services are focused on all aspects of cardiac care, including the catheterization lab.</p> <p> </p> <p></p><p> </p> </div> <span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="http://www.dicardiology.com/content/rwjbarnabas-health-earns-acc-cardiac-cath-lab-recognition" data-a2a-title="RWJBarnabas Health Earns ACC Cardiac Cath Lab Recognition "><hr /><h4 class="share-title">If you enjoy this content, please share it with a colleague</h4><a class="a2a_button_email"></a><a class="a2a_button_facebook"></a><a class="a2a_button_twitter"></a><a class="a2a_button_linkedin"></a><a class="a2a_dd addtoany_share" href="https://www.addtoany.com/share#url=http%3A%2F%2Fwww.dicardiology.com%2Fcontent%2Frwjbarnabas-health-earns-acc-cardiac-cath-lab-recognition&title=RWJBarnabas%20Health%20Earns%20ACC%20Cardiac%20Cath%20Lab%20Recognition%20"></a></span> </article> <article> <h1>FDA Grants Coredio Breakthrough Designation for AI Platform</h1> <p>tim.hodson — Thu, 28 May 2026 15:44:57 +0000</p> <div class="field field--name-field-image field--type-image field--label-hidden field--items"> <div class="field--item"> </div> </div> <span><span lang="" about="http://www.dicardiology.com/users/timhodson" typeof="schema:Person" property="schema:name" datatype="" xml:lang="">tim.hodson</span></span> <span>Thu, 05/28/2026 - 10:44</span> <div class="field field--name-body field--type-text-with-summary field--label-hidden field--item"><p>May 28, 2026 — <a href="http://www.coredio-ai.com">Coredio</a> has announced that the U.S. Food and Drug Administration (FDA) has granted its Cardiac Performance Simulation Engine (CPSE) Breakthrough Device Designation and accepted the platform into the FDA’s Total Product Life Cycle Advisory Program (TAP). CPSE is a software-only platform designed to deliver catheterization-comparable hemodynamic assessment using consumer smartwatches and standard blood pressure cuffs in clinical and home settings under physician supervision.</p> <p>Coredio is now on an accelerated, priority path toward 510(k) submission. For many HF patients, the most vulnerable period begins when they leave the hospital. Clinicians often lose visibility into cardiac decompensation until symptoms become severe enough to trigger another ER visit or hospital readmission.</p> <p>“Heart failure management has long been limited by the gap between what we can measure in the hospital and what we can reliably understand once patients return home,” said Dr. Jagmeet P. Singh, MD, PhD, Mass General Brigham. “Coredio’s approach, using wearable-derived signals and physics-informed AI to estimate hemodynamic status noninvasively, has the potential to give clinicians a more holistic view of patient cardiac function and enable earlier intervention.”</p> <p>CPSE is device-agnostic and designed to bring hemodynamic assessment into the home and physician office using wearables patients already own.</p> <p>CPSE is a software-only platform with proprietary algorithms designed to identify abnormal status across four key hemodynamic parameters used by cardiologists to assess whether HF patients are stable or deteriorating. These include left ventricular end-diastolic pressure (LVEDP), central venous pressure (CVP), systemic vascular resistance (SVR), and cardiac index (CI), enabling a more holistic view of both left- and right-sided HF.</p> <p>“At White Plains Hospital, our transitional care program focuses on the critical weeks after discharge, when heart failure patients are most vulnerable and least connected to their care team,” said Dr. Farrukh Jafri, MD, White Plains Hospital. “What drew us to Coredio is its potential to bring hemodynamic-level data into that gap, without requiring invasive devices or additional clinical visits.”</p> <p>CPSE pairs a physics-based digital twin of the patient's cardiovascular system with machine learning trained on clinical data. After an initial personalization step, patients use a smartwatch and standard blood pressure cuff for on-demand indication of hemodynamicstatus for clinician review.</p> <p>“Heart failure management has long been limited by the gap between what we can assess invasively or with imaging tools and what we can see at home,” said Dr. Jennifer Monti, Cardiologist, SSM Health. “Coredio’s approach, extracting catheterization-comparable hemodynamic data from consumer wearables using physics-based AI, has the potential to close that gap and give clinicians the visibility they need to intervene earlier and make moreinformed decisions for heart failure patients.”</p> <h4>FDA Breakthrough Device Designation</h4> <p>“We’re proud that Coredio has been granted FDA Breakthrough Device Designation and is enrolled in TAP” said Mehdi Mortazawy, Co-Founder & CTO, Coredio. “CPSE fuses a physics-based digital twin of the cardiovascular system with advanced AI to noninvasively classify the four hemodynamic parameters central to HF management. These designations from FDA reflect the scientific rigor and the urgency of the unmet need in HF management and how Coredio is poised to help cardiology specialists and their patients meet this need in the future.”</p> <p> </p> <p></p><p> </p> </div> <span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="http://www.dicardiology.com/content/fda-grants-coredio-breakthrough-designation-ai-platform" data-a2a-title="FDA Grants Coredio Breakthrough Designation for AI Platform "><hr /><h4 class="share-title">If you enjoy this content, please share it with a colleague</h4><a class="a2a_button_email"></a><a class="a2a_button_facebook"></a><a class="a2a_button_twitter"></a><a class="a2a_button_linkedin"></a><a class="a2a_dd addtoany_share" href="https://www.addtoany.com/share#url=http%3A%2F%2Fwww.dicardiology.com%2Fcontent%2Ffda-grants-coredio-breakthrough-designation-ai-platform&title=FDA%20Grants%20Coredio%20Breakthrough%20Designation%20for%20AI%20%20Platform%C2%A0%C2%A0"></a></span> </article> </main></body></html>