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My creditcard records an ECG of my heart Here is th first credit card-sized device which allows patients at all times to record an ECG whenever they feel symptoms and reduce delays in care. HeartBeam Inc. (NASDAQ: BEAT) (https://www.heartbeam.com/) is the first cable-free, ambulatory ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics. Easy to place yourself, and linked to an accompanying App. Company to initiate Early Access Program to gain important patient and physician feedback on the use of the system in preparation for commercial launch The US Food and Drug Administration (FDA) has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment. With its patented design, the HeartBeam device is the first-of-its-kind to receive FDA clearance. As a high-fidelity electrocardiogram (ECG) system with a credit card-sized form factor and cable-free design, it captures heart signals from three distinct directions for actionable heart health information. #mhealth #digitalhealth #cardiology #remotemonitoring #homecare #selfcare

🚨 Attention Medical Device Manufacturers! 🚨 The Gemeinsame Bundesausschuss (G-BA) is inviting your input on the use of phonocardiography for diagnosing coronary heart disease! 🫀 Key Details: - 📅 Submission Deadline: January 2, 2025 - 📄 Comprehensive German-language documentation required - 🗣️ Opportunity to present at G-BA hearings and influence national guidelines This is your chance to shape the future of diagnostic practices and ensure your devices meet emerging healthcare standards. Don't miss out on this strategic opportunity to align with health technology assessments and enhance product integration in the German market. 👉 Click the link for more information on how to participate! #CoronaryHeartDisease #G-BA #GBABoard #HealthcareInnovation #MedTech #MedicalDevices #Phonocardiography #RegulatoryAgencies #MarketAccess #MarketAccessToday

Key takeaways: 6 months is not a long time 🥸, however this news is encouraging 😁 🔹 Abbott’s Aveir DR leadless pacemaker, the world’s very first dual-chamber pacing solution of its kind, is associated with a “reliable” performance after six months, according to new data published in Heart Rhythm.[1] 🔷 The Aveir DR system includes both an atrial leadless pacemaker (ALP) and a ventricular leadless pacemaker (VLP). The two devices were designed to communicate with one another as needed, helping patients with abnormal heart rhythms receive the care they need at any given time. 🔹 The U.S. Food and Drug Administration (FDA) approved the new-look device in July 2023, making leadless pacing available to a much wider patient population. While single-chamber leadless pacing has been around for several years, most bradycardia patients require dual-chamber pacing.

Key takeaways: 🔹 Abbott’s Aveir DR leadless pacemaker, the world’s very first dual-chamber pacing solution of its kind, is associated with a “reliable” performance after six months, according to new data published in Heart Rhythm.[1] 🔷 The Aveir DR system includes both an atrial leadless pacemaker (ALP) and a ventricular leadless pacemaker (VLP). The two devices were designed to communicate with one another as needed, helping patients with abnormal heart rhythms receive the care they need at any given time. 🔹 The U.S. Food and Drug Administration (FDA) approved the new-look device in July 2023, making leadless pacing available to a much wider patient population. While single-chamber leadless pacing has been around for several years, most bradycardia patients require dual-chamber pacing.

𝗔 𝗻𝗲𝘄 𝗲𝗿𝗮 𝗶𝗻 𝗰𝗮𝗿𝗱𝗶𝗮𝗰 𝗺𝗮𝗽𝗽𝗶𝗻𝗴 𝗯𝗲𝗴𝗶𝗻𝘀! 📢 Congratulations to Andreu M. Climent and the entire team at Corify for securing CE mark approval for the Acorys cardiac mapping system! This milestone under the new MDR regulations showcases Corify's commitment to revolutionizing cardiac care. The Acorys system is a game-changer in diagnosing and treating cardiac arrhythmias, offering non-invasive, real-time visualization of the heart's electrical activity without the need for CT or MRI scans. By utilizing body surface potential and a 3D torso model, Acorys creates detailed electroanatomical maps, enhancing precision and speed in diagnosing conditions like AFib while prioritizing patient safety and comfort. The potential impact on patient care and clinical outcomes is immense, and it's exciting to see this innovation being integrated into hospitals across Europe and beyond. As Corify Care looks toward FDA approval and the development of Acorys 2.0, incorporating digital twins and new clinical applications, the future of cardiac care appears brighter than ever. Here's to pioneering advancements and improving patient outcomes worldwide! 👏 Congratulations once again to Andreu M. Climent and the Corify Care team! Looking forward to seeing Acorys transform cardiac mapping and patient care globally. #CorifyCare #CardiacMapping #CEApproval #MedicalDevices #PatientCare #CardiacArrhythmia

HeartBeam Announces FDA Clearance for At-Home, High-Fidelity Heart Monitoring Technology o First cable-free, ambulatory ECG that captures the heart’s electrical signals from three distinct directions for high-fidelity data collection and advanced diagnostics o Patients can have the credit card-sized device with them at all times, ready to record an ECG whenever they feel symptoms and reduce delays in care o Company to initiate Early Access Program to gain important patient and physician feedback on the use of the system in preparation for commercial launch READ FULL PRESS RELEASE - https://lnkd.in/gqayv6rR

#AbbottProud #IWorkAtAbbott I am happy to share that after 3 years of hard work between the Abbott Diabetes Care (ADC) and Abbott Cardiac Rhythm Management (CRM) teams, we have formally published our technology report in the Journal of Diabetes Science and Technology (JDST)! This investigation focused on the accuracy and functionality of FreeStyle Libre systems when in the presence of active implantable cardioverter defibrillators (ICDs) and wireless interference devices. I would like to personally thank William Matievich, Michael Tao, and Kevin Kastanos from ADC for allowing me the honor and privilege of being the lead author on this report. Additionally, I would like to thank Umesh Shah and Arnab (Rana) Banerjee for their active involvement and support on all CRM activities. Methods: This evaluation assessed whether FreeStyle Libre (FL) CGM systems can coexist and function within the same patient in the presence of wireless interference devices, including current ICD devices. Interferer sources included Wi-Fi devices, Bluetooth devices, cellular mobile devices, implantable medical devices, Bluetooth Low-Energy (BLE) devices, BLE accessory devices and BLE mobile devices, and ICD-programmer interferers. Five testing methodologies were used to evaluate the accuracy and functionality of the CGM systems when exposed to ICD functions: high-energy emergency shocking, pacing modes, anti-tachycardia pacing mode (ATP), and DC Fibber mode. Conclusions: Our findings demonstrated that coexisting ICD devices and FL CGM systems provide safe and effective wireless communications with functional and accurate transfer of data during scenarios expected in clinical use. For full access, please visit the following link: https://lnkd.in/g6aRj-9Y

HeartBeam Inc. (NASDAQ: BEAT) 𝐆𝐚𝐢𝐧𝐬 𝐅𝐃𝐀 510(𝐤) 𝐂𝐥𝐞𝐚𝐫𝐚𝐧𝐜𝐞 𝐟𝐨𝐫 𝐏𝐨𝐫𝐭𝐚𝐛𝐥𝐞 𝐀𝐫𝐫𝐡𝐲𝐭𝐡𝐦𝐢𝐚 𝐀𝐬𝐬𝐞𝐬𝐬𝐦𝐞𝐧𝐭 𝐒𝐲𝐬𝐭𝐞𝐦 HeartBeam Inc. (NASDAQ: BEAT) has received #FDA 510(k) clearance for its innovative, credit card-sized arrhythmia assessment device, the first of its kind to achieve this milestone. The portable, cable-free device allows users to record a 30-second ECG via a simple chest placement and transmits data to the cloud for physician review. Designed for adult use in clinical or home settings, the device captures 3-Lead ECG data using five electrodes. While it does not perform automated analysis, it integrates with ECG Viewer software, enabling healthcare providers to interpret non-life-threatening arrhythmias manually. HeartBeam Inc. (NASDAQ: BEAT) CEO Rob Eno stated: "The ability for patients to capture high-fidelity ECG signals wherever they are will help them receive care sooner, improving outcomes. FDA clearance is a major step toward delivering unprecedented cardiac insights to individuals and physicians." HeartBeam Inc. (NASDAQ: BEAT) plans to integrate AI to analyze ECG data for predictive insights and provide a longitudinal view of cardiac health. The company will launch an Early Access Program, with a waitlist now open for patients and physicians. https://lnkd.in/eybDP3nC

🤍 Restore Medical secured FDA breakthrough device designation for its ContraBand system to treat left ventricle failure. The device is claimed to be the first transcatheter pulmonary artery banding system in the world to improve the patient’s quality of life. 💬 Restore Medical, led by CEO Gilad Marom, stated: “This designation marks a significant milestone in the company’s mission towards the improvement of cardiac care for heart failure patients as it highlights the potential of the ContraBand device to address critical unmet needs in the treatment of HFrEF patients.” 👉 Learn more: https://lnkd.in/dXfN23Mc 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dvz_fgir #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #HealthTech #Surgeons #GuidedSolutions

Penumbra, Inc. announced the U.S. Food and Drug Administration (FDA) clearance and launch of Lightning Flash™ 2.0, the next generation computer assisted vacuum thrombectomy (CAVT) system to remove venous thrombus and treat pulmonary emboli (PE). Lightning Flash 2.0 features advanced Lightning Flash algorithms, designed for increased speed and sensitivity to thrombus and blood flow. These new advancements combined with Penumbra’s novel catheter technology allow physicians to better navigate the body’s complex anatomy and deliver high power for clot removal with possible minimal blood loss. Read More: https://lnkd.in/dpa-TkyE “Based on what we’ve seen in the initial launch, Lightning Flash 2.0 has significantly improved procedure time by shortening the aspiration time. It has also shown reductions in blood removed during aspiration. These advantages can improve patient safety, provide better outcomes for the patients, and streamline efficiency for physicians treating the patients,” said James F. Benenati, M.D., FSIR, chief medical officer at Penumbra. “As adoption of thrombectomy becomes more widespread, Lightning Flash 2.0 will provide physicians with the confidence that CAVT is a valuable frontline option.” “Lightning Flash 2.0 now combines an optimally sized catheter with the latest algorithm technology designed to more efficiently remove blood clots while maintaining a high level of safety,” said Adam Elsesser, president and chief executive officer of Penumbra #mededgemea #CAVT #MedicalTechnology #cardiology #vascularhealth #InnovativeTechnology #healthtech #hearthealth #cardiovascular #HealthcareNews #MedicalDevices #healthcareinnovation #patientcare #healthcaretechnology