{"id":30255,"date":"2024-11-07T16:28:06","date_gmt":"2024-11-07T10:58:06","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=30255"},"modified":"2024-11-07T16:28:08","modified_gmt":"2024-11-07T10:58:08","slug":"medtech-news-for-beta-bionics-philips-seemedx","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx","title":{"rendered":"Beta Bionics Introduces iLet Bionic Pancreas with Abbott\u2019s FreeStyle Libre 3 Integration; Merit Medical Successfully Acquires Cook Medical&#8217;s Lead Management Portfolio; Elixir Medical\u2019s LithiX HC-IVL System Maintains Safety and Efficacy at Six-Month Mark; Philips Launches U.S. Clinical Trial with First Patient Enrolled for New Integrated Device for PAD; FDA Grants iRhythm Technologies 510(k) Clearance for Enhanced Zio AT Device; SeeMedX Submits 510(k) for Cardiac Monitoring System Aiming to Revolutionize Heart Failure Management"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a10988a7d473\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a10988a7d473\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx\/#Beta_Bionics_Launched_iLet_Bionic_Pancreas_Along_With_Abbotts_FreeStyle_Libre_3_Plus_sensor\" >Beta Bionics Launched iLet Bionic Pancreas Along With Abbott\u2019s FreeStyle Libre 3 Plus sensor&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx\/#Merit_Medical_Completed_the_Acquisition_of_the_Lead_Management_Portfolio_from_Cook_Medical\" >Merit Medical Completed the Acquisition of the Lead Management Portfolio from Cook Medical&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx\/#LithiX_HC-IVL_System_by_Elixir_Medicals_Demonstrated_Sustained_Safety_and_Efficacy_at_Six_Months\" >LithiX HC-IVL System by Elixir Medical\u2019s Demonstrated Sustained Safety and Efficacy at Six Months&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx\/#Philips_Enrolled_the_First_Patient_in_the_US_Clinical_Trial_for_Innovative_Integrated_Single-Device_to_Treat_Peripheral_Artery_Disease\" >Philips Enrolled the First Patient in the U.S. Clinical Trial for Innovative Integrated Single-Device to Treat Peripheral Artery Disease&nbsp;<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-5\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx\/#SeeMedX_Filed_510k_with_the_FDA_for_an_Innovative_Cardiac_Monitoring_System_to_Transform_Heart_Failure_Care\" >SeeMedX Filed 510(k) with the FDA for an Innovative Cardiac Monitoring System to Transform Heart Failure Care&nbsp;<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-beta-bionics-launched-ilet-bionic-pancreas-along-with-abbott-s-freestyle-libre-3-plus-sensor-nbsp\"><span class=\"ez-toc-section\" id=\"Beta_Bionics_Launched_iLet_Bionic_Pancreas_Along_With_Abbotts_FreeStyle_Libre_3_Plus_sensor\"><\/span><strong>Beta Bionics Launched iLet Bionic Pancreas Along With Abbott\u2019s FreeStyle Libre 3 Plus sensor&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On October 30, 2024, Beta Bionics, Inc., a leader in developing advanced diabetes management solutions, announced the launch of its iLet Bionic Pancreas and its integration with Abbott\u2019s FreeStyle Libre\u00ae 3 Plus sensor.<\/p>\n\n\n\n<p>The iLet Bionic Pancreas, Beta Bionics&#8217; flagship product, is a self-contained insulin delivery device that simplifies diabetes management and eases the load on patients, caregivers, and clinicians. The iLet is the first insulin delivery system in the United States to connect to Abbott&#8217;s FreeStyle Libre 3 Plus sensor, which takes readings every minute and helps the iLet calculate insulin doses.&nbsp;<\/p>\n\n\n\n<p>When iLet users &#8220;GO BIONIC&#8221; with their diabetes care, there is no need to count carbs* or calculate insulin corrections during the day; the iLet determines 100% of insulin dosages and continuously learns and adapts to the user. The user&#8217;s weight is the sole input required to start using the iLet.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201cBeta Bionics continues to move at lightning speed to bring these enhancements to our userbase,\u201d said Sean Saint, CEO of Beta Bionics. \u201cWith our recent launch of the Bionic Circle remote monitoring app, our latest updates to the iLet app, and today\u2019s launch of the iLet integration with Abbott\u2019s FreeStyle Libre 3 Plus sensor, we are focused on providing major product enhancements to make diabetes management even easier for our users and their families.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p>The Beta Bionics Bionic Circle App lets users invite up to ten friends and family members to monitor their CGM levels and insulin doses remotely. Bionic Circle members can get alerts and see an iLet user&#8217;s glucose levels, meal announcements, insulin dosages, and trends all day and night.<\/p>\n\n\n\n<p>This integration gives users a new option to control type 1 diabetes. With both Beta Bionics and FreeStyle Libre&#8217;s capacity to sell products through the pharmacy channel, users of the integrated platform can benefit from the convenience of purchasing supplies through an innovative pay-as-you-go model.&nbsp;<\/p>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/insulin-delivery-devices-market\"><strong>Insulin Delivery Devices Market Report<\/strong><\/a>\u201d, the global insulin delivery devices market was valued at <strong>USD 15.51 billion<\/strong> in 2023, growing at a <strong>CAGR of 9.28%<\/strong> during the forecast period from 2024 to 2030, to reach <strong>USD 26.35 billion<\/strong> by 2030. The rise in demand for insulin delivery devices is predominantly driven by the increasing prevalence of diabetes due to lifestyle changes, aging populations, and genetic factors. Secondly, awareness campaigns and educational initiatives have significantly increased public knowledge about diabetes management. Patients and healthcare providers are now more informed about the benefits of using advanced insulin delivery devices, which offer precise dosing, convenience, and improved blood glucose control compared to traditional methods. Technological advancements have also fueled market growth by introducing innovative features such as smart insulin pumps, continuous glucose monitor (CGM) integration, and mobile app connectivity. Collectively, these factors create a robust market environment that drives the demand for insulin delivery devices, ensuring better health outcomes for diabetes patients, during the forecast period from 2024 to 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-merit-medical-completed-the-acquisition-of-the-lead-management-portfolio-from-cook-medical-nbsp\"><span class=\"ez-toc-section\" id=\"Merit_Medical_Completed_the_Acquisition_of_the_Lead_Management_Portfolio_from_Cook_Medical\"><\/span><strong>Merit Medical Completed the Acquisition of the Lead Management Portfolio from Cook Medical&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On November 1, 2024, Merit Medical Systems, Inc., announced that it finalized the acquisition of Cook Medical&#8217;s lead management portfolio.&nbsp;<\/p>\n\n\n\n<p>The purchase cost included a cash payment of about USD 210 million and the assumption of certain liabilities. Merit paid the acquisition price with a combination of cash on hand and borrowings from its long-term credit facility.<\/p>\n\n\n\n<p>Cook Medical&#8217;s lead management division offers a complete line of medical devices and accessories used in lead management procedures for patients who require the removal or replacement of a pacemaker or an implanted cardioverter-defibrillator lead.&nbsp;<\/p>\n\n\n\n<p>Merit&#8217;s electrophysiology and CRM portfolio, in addition to the lead management portfolio purchased from Cook Medical, comprises steerable and other specialist technologies that assist electrophysiologists in accessing the heart to diagnose and deliver cardiac rhythm problem treatments.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201cWe are pleased to announce the completion of this important acquisition,\u201d said Fred P. Lampropoulos, Merit\u2019s Chairman and Chief Executive Officer. \u201cWe are excited to welcome the talented team from Cook Medical\u2019s lead management business. We believe this acquisition will strengthen our fast-growing, high-margin electrophysiology and CRM business, as well as enhance our position in the global cardiac intervention market.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p>As per DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/electrophysiology-devices-market\"><strong>Electrophysiology Devices Market Report<\/strong><\/a>\u201d, the electrophysiology devices market was valued at <strong>USD 6.31 billion<\/strong> in 2023, growing at a <strong>CAGR of 9.73%<\/strong> during the forecast period from 2024 to 2030, to reach <strong>USD 9.22 billion<\/strong> by 2030. The electrophysiology devices market is growing significantly due to the increasing cases of chronic disorders such as cardiovascular diseases including atrial fibrillation and coronary artery disease (CAD) with the rising shift towards minimally invasive approaches, innovative product developmental activities by leading companies, and rising geriatric population which are expected to escalate the to the overall growth of the electrophysiology devices market during the forecast period from 2024 to 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-lithix-hc-ivl-system-by-elixir-medical-s-demonstrated-sustained-safety-and-efficacy-at-six-months-nbsp\"><span class=\"ez-toc-section\" id=\"LithiX_HC-IVL_System_by_Elixir_Medicals_Demonstrated_Sustained_Safety_and_Efficacy_at_Six_Months\"><\/span><strong>LithiX HC-IVL System by Elixir Medical\u2019s Demonstrated Sustained Safety and Efficacy at Six Months&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On October 30, 2024, Elixir Medical&#8217;s LithiX\u2122 Hertz Contact (HC) Intravascular Lithotripsy System (IVL) was found to be safe and effective for treating moderate to severely calcified coronary artery lesions in the PINNACLE I research after six months of use.<\/p>\n\n\n\n<p>The revolutionary LithiX Hertz Contact IVL system is the first non-energy IVL device developed to fragment moderate to severe calcified lesions that are refractory to optimal stent expansion. The LithiX IVL mechanism of action is based on the physics principle of Hertz Contact Stress, which propagates the required discrete forces to fragment calcium without causing vessel injury, requires no energy source or capital equipment, and has a positive impact on PCI procedure workflow by shortening procedure times and simplifying the learning curve.<\/p>\n\n\n\n<p>LithiX data results demonstrated:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>98.3% clinical success (primary effectiveness and safety outcome) with 100% angiographic success over a range of moderate to severe calcium morphologies.<\/li>\n\n\n\n<li>All lesions had a residual diameter stenosis of less than 30%.<\/li>\n\n\n\n<li>There were no angiographic problems, such as severe dissections, perforation, or abrupt closure after stenting.&nbsp;<\/li>\n\n\n\n<li>The procedure was safe and effective, with just one peri-procedural non-Q-wave myocardial infarction and a 1.7% TLF event rate over 6 months.<\/li>\n<\/ul>\n\n\n\n<p>An intravascular imaging sub-study with optical coherence tomography (OCT) was carried out to precisely measure the lesion complexity and calcium fragmentation efficiency of LithiX IVL across a variety of complicated calcium shapes.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201cThe cardiology community has long sought solutions that can better treat patients with calcified lesions to achieve optimal PCI outcomes,\u201d said Johan Bennett, M.D., study principal investigator and director of CTO\/CHIP program at the University Hospital Leuven in Leuven, Belgium. \u201cThe six-month PINNACLE I data are a strong validation of LithiX IVL\u2019s mechanism of action that can safely fragment calcium across a range of complex morphologies without trauma to the soft tissue and can be easily integrated into standard PCI procedure workflow without the need for an energy source.\u201d<\/p>\n<\/blockquote>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201cWe developed LithiX to improve the IVL treatment of calcified lesions with shorter procedure times and effectiveness across a broad range of calcified lesions, and we\u2019re delighted with the PINNACLE I study outcomes demonstrating its sustained safety and effectiveness,\u201d said Motasim Sirhan, CEO of Elixir Medical. \u201cOur team is committed to developing transformative cardiovascular technologies that deliver improved physician experiences and most importantly, better clinical outcomes for patients.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/lithotripsy-devices-market\"><strong>Lithotripsy Devices Market Report<\/strong><\/a>\u201d, the lithotripsy devices market was valued at <strong>USD 1.39 billion<\/strong> in 2023, growing at a <strong>CAGR of 4.32%<\/strong> during the forecast period from 2024 to 2030 to reach <strong>USD 1.78 billion<\/strong> by 2030. The lithotripsy devices market is growing significantly due to the rising prevalence of urolithiasis, technological advancements in product development, increased risk of end-stage renal failure, and rising awareness for the procedure is expected to escalate the demand for lithotripsy devices during the forecast period from 2024 to 2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-philips-enrolled-the-first-patient-in-the-u-s-clinical-trial-for-innovative-integrated-single-device-to-treat-peripheral-artery-disease-nbsp\"><span class=\"ez-toc-section\" id=\"Philips_Enrolled_the_First_Patient_in_the_US_Clinical_Trial_for_Innovative_Integrated_Single-Device_to_Treat_Peripheral_Artery_Disease\"><\/span><strong>Philips Enrolled the First Patient in the U.S. Clinical Trial for Innovative Integrated Single-Device to Treat Peripheral Artery Disease&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On November 4, 2024, Royal Philips, announced the enrollment of the first patient in the U.S. THOR IDE clinical trial, which will study an innovative combined laser atherectomy and intravascular lithotripsy catheter developed by Philips, that integrates two critical PAD treatments into a single device.<\/p>\n\n\n\n<p>Procedures that previously required the use of two different devices can now be completed in a single procedure with a single device, simplifying workflows and procedures and potentially lowering risk and increasing results for patients who would otherwise require multiple difficult interventions.&nbsp;<\/p>\n\n\n\n<p>The purpose of this pivotal study is to assess the safety and efficacy of using this novel laser device, which combines laser atherectomy and intravascular lithotripsy in a single device, to treat complex, calcified lesions in a single procedure for patients with peripheral artery disease (PAD), restoring blood flow to their legs.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201cDeveloping and driving clinical evidence is crucial to improving care and guiding the adoption of new technologies like the Philips laser atherectomy and lithotripsy system,\u201d said Drs. Craig Walker, Pradeep Nair, and McCall Walker of Cardiovascular Institute of the South in Louisiana. \u201cThis trial will provide essential data to demonstrate how this combined approach can optimize procedural efficiency and patient outcomes in treating challenging calcified lesions.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p>The prospective, single-arm, multicenter trial will include up to 155 patients from up to 30 sites in the United States. The study, which is being conducted under an Investigational Device Exemption (IDE) from the United States Food and Drug Administration (FDA), will evaluate the system&#8217;s safety and effectiveness in attaining procedural success while minimizing problems.<\/p>\n\n\n\n<p>The study&#8217;s primary endpoints include the absence of major adverse events (MAEs) such as mortality, unplanned amputations, and clinically driven target lesion revascularization (CD-TLR) within 30 days (about four and a half weeks) of the procedure, as well as the achievement of less than or equal to 50% residual stenosis post-procedure. Patients will be monitored for twelve months.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201cThis innovative approach to vessel preparation could improve patient outcomes while minimizing the need for multiple therapies and interventions. That makes this an exciting innovation milestone as we enroll the first patient in this important U.S. clinical trial,\u201d said Dr. Genovese, MD, vascular surgeon and co-principal investigator of the THOR* trial at the Penn Advanced Limb Preservation, Hospital of the University of Pennsylvania. \u201cIntegrating atherectomy and intravascular lithotripsy into a single device has the potential to revolutionize the treatment of patients with complex femoropopliteal lesions associated with moderate to severe calcifications.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/atherectomy-devices-market\"><strong>Atherectomy Devices Market Report<\/strong><\/a>\u201d, the global atherectomy devices market was valued at <strong>USD 939 million<\/strong> in 2023, growing at a <strong>CAGR of 9.24%<\/strong> during the forecast period from 2024 to 2030 to reach <strong>USD 1,596 million<\/strong> by 2030. The demand for atherectomy devices is primarily being boosted by the increasing geriatric population, rising prevalence of cardiovascular diseases, growing prevalence of lifestyle disorders such as hypertension and diabetes, and innovation in product development thereby contributing to the overall growth of the atherectomy devices market during the forecast period.<\/p>\n\n\n\n<p>iRhythm Technologies Received FDA 510(k) Clearance for Design Modifications for Zio\u00ae AT Device&nbsp;<\/p>\n\n\n\n<p>On October 30, 2024, iRhythm Technologies, Inc. stated that the US Food and Drug Administration (FDA) approved its 510(k) filing for design changes and labeling updates for the Zio AT device. Zio AT remains commercially accessible for shipment to clients in the United States, and product upgrades under this 510(k) clearance will be available in 2025.<\/p>\n\n\n\n<p>The Zio AT gadget is designed to capture and transmit both symptomatic and asymptomatic cardiac events, as well as record continuous electrocardiogram (ECG) data for long-term monitoring. It is recommended for individuals 18 and older who are asymptomatic or have temporary symptoms such as palpitations, shortness of breath, dizziness, lightheadedness, syncope, weariness, or anxiety. It is not intended for use with critical care patients.<\/p>\n\n\n\n<p>The Zio AT device is a prescription-only outpatient cardiac telemetry device, often known as a mobile cardiac telemetry device, that is used to deliver our mobile cardiac telemetry (MCT) services. The Zio AT system consists of three components: the Zio AT patch, an ECG monitor that continuously records ECG data for up to 14 days; the wireless gateway, which connects the Zio AT patch to the Zio ECG Utilization Software (ZEUS) and transmits data during the wear period; and ZEUS, iRhythm&#8217;s deep-learning algorithm that analyzes cardiac events transmitted by the Zio AT patch and gateway.&nbsp;<\/p>\n\n\n\n<p>The Zio AT services give event transmission reports during wear, as well as a comprehensive end-of-wear report1-4 with preliminary findings for the treating medical professional to make final therapeutic decisions.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>\u201cThis clearance is related to enhancements to our Zio AT product, including design features and labeling updates intended to address areas of concern specific to Zio AT that were noted in a 2023 FDA warning letter to the Company,\u201d said Quentin Blackford, iRhythm President and Chief Executive Officer. \u201cWe believe these features that were subject to this clearance advance our technology for the benefit of patients, physicians, and healthcare systems who rely on our Zio AT services. At all times, we remain committed to patient safety, physician trust in Zio AT\u2019s clinical performance, service quality, and regulatory compliance.\u201d<\/p>\n<\/blockquote>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/ecg-telemetry-devices-market\"><strong>ECG Telemetry Devices Market Report<\/strong><\/a>\u201d, the global ECG telemetry devices market is estimated to grow at a <strong>CAGR of 7.29%<\/strong> during the forecast period from 2024 to 2030. The demand for ECG telemetry devices is primarily being boosted by the rising prevalence of coronary heart disease across the globe. Further, the rising cases of patients with chronic diseases, the increasing patient admission in intensive care, increasing awareness about self-assessment of heart rhythm, increasing demand for telemedicine, and innovation in product development among others are thereby contributing to the overall growth of the ECG telemetry devices market during the forecast period from 2024-2030.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-seemedx-filed-510-k-with-the-fda-for-an-innovative-cardiac-monitoring-system-to-transform-heart-failure-care-nbsp\"><span class=\"ez-toc-section\" id=\"SeeMedX_Filed_510k_with_the_FDA_for_an_Innovative_Cardiac_Monitoring_System_to_Transform_Heart_Failure_Care\"><\/span><strong>SeeMedX Filed 510(k) with the FDA for an Innovative Cardiac Monitoring System to Transform Heart Failure Care&nbsp;<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On November 4, 2024, SeeMedX Inc., announced that it&nbsp;submitted a 510(k) premarket notification to the United States Food and Drug Administration (FDA) for its innovative, non-invasive cardiac monitoring device, which is designed to provide medical professionals with real-time insights into cardiac performance and fluid status.&nbsp;<\/p>\n\n\n\n<p>SeeMedX&#8217;s technology enables clinicians to make more educated decisions about heart failure treatment, resulting in faster and safer outcomes than current options. SeeMedX&#8217;s non-invasive cardiac gadget measures accurate hemodynamic parameters such as Zo (fluid status) and CO (cardiac output), allowing clinicians to detect volume overload and other heart failure signs earlier than traditional approaches.<\/p>\n\n\n\n<p>It provides actionable data on Zo (fluid status) and CO (cardiac output), allowing clinicians to make more prompt decisions for optimal heart failure treatment. It also improves patient comfort and clinical efficiency by being non-invasive, allowing for faster treatments, increasing hospital efficiency, and enabling prompt clinical choices.<\/p>\n\n\n\n<blockquote class=\"wp-block-quote is-layout-flow wp-block-quote-is-layout-flow\">\n<p>&#8220;This submission marks a major milestone for SeeMedX in advancing heart failure care,&#8221; said Deborah Simpson, CEO of SeeMedX. &#8220;After the unexpected loss of my father, I made it my personal mission to develop a life-changing solution for heart failure treatment. Our goal is to empower clinicians with tools that ultimately improve outcomes for patients everywhere.&#8221;<\/p>\n<\/blockquote>\n\n\n\n<p>According to DelveInsight\u2019s \u201c<a href=\"https:\/\/www.delveinsight.com\/report-store\/cardiac-monitoring-devices-market\"><strong>Cardiac Monitoring Devices Market Report<\/strong><\/a>\u201d, the cardiac monitoring device market is estimated to grow at a <strong>CAGR of 5.4%<\/strong> during the forecast period from 2024 to 2030. The cardiac monitoring device market is observing substantial market growth primarily owing to the increasing cases of chronic disorders such as cardiovascular diseases including atrial fibrillation and coronary artery disease (CAD) with the rising shift towards minimally invasive approaches, innovative product developmental activities by leading companies, and rising geriatric population are expected to escalate the overall growth of the cardiac monitoring devices market during the forecast period from 2024 to 2030.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Beta Bionics Launched iLet Bionic Pancreas Along With Abbott\u2019s FreeStyle Libre 3 Plus sensor&nbsp; On October 30, 2024, Beta Bionics, Inc., a leader in developing advanced diabetes management solutions, announced the launch of its iLet Bionic Pancreas and its integration with Abbott\u2019s FreeStyle Libre\u00ae 3 Plus sensor. The iLet Bionic Pancreas, Beta Bionics&#8217; flagship product, [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":30263,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[20577,17110,22329,22350,18892,22351,17021,16975,5789],"industry":[17226],"therapeutic_areas":[17242,17240],"class_list":["post-30255","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-atherectomy-devices","tag-cardiac-monitoring-devices","tag-ecg-telemetry-devices","tag-electrophysiology-devices","tag-insulin-delivery-devices","tag-lithotripsy-devices","tag-medical-devices-market","tag-medtech-market","tag-recent-pharma-news","industry-medical-devices","therapeutic_areas-cardiovascular-diseases","therapeutic_areas-endocrinology-and-metabolic-disorders"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>MedTech News | Beta Bionics, Philips, SeeMedX<\/title>\n<meta name=\"description\" content=\"Beta Bionics\u2019 iLet Bionic Pancreas; Merit Medical\u2019s Acquisition; Elixir Medical\u2019s LithiX HC-IVL System; iRhythm Technologies\u2019 Zio AT Device\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"MedTech News | Beta Bionics, Philips, SeeMedX\" \/>\n<meta property=\"og:description\" content=\"Beta Bionics\u2019 iLet Bionic Pancreas; Merit Medical\u2019s Acquisition; Elixir Medical\u2019s LithiX HC-IVL System; iRhythm Technologies\u2019 Zio AT Device\" \/>\n<meta property=\"og:url\" content=\"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx\" \/>\n<meta property=\"og:site_name\" content=\"DelveInsight Business Research\" \/>\n<meta property=\"article:publisher\" content=\"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/\" \/>\n<meta property=\"article:published_time\" content=\"2024-11-07T10:58:06+00:00\" \/>\n<meta property=\"article:modified_time\" content=\"2024-11-07T10:58:08+00:00\" \/>\n<meta property=\"og:image\" content=\"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/11\/07162755\/medtech-news-for-beta-bionics-philips-seemedx.png\" \/>\n\t<meta property=\"og:image:width\" content=\"772\" \/>\n\t<meta property=\"og:image:height\" content=\"482\" \/>\n\t<meta property=\"og:image:type\" content=\"image\/png\" \/>\n<meta name=\"author\" content=\"Sandeep Joshi\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:creator\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:site\" content=\"@DelveInsight\" \/>\n<meta name=\"twitter:label1\" content=\"Written by\" \/>\n\t<meta name=\"twitter:data1\" content=\"Sandeep Joshi\" \/>\n\t<meta name=\"twitter:label2\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data2\" content=\"9 minutes\" \/>\n<!-- \/ Yoast SEO Premium plugin. -->","yoast_head_json":{"title":"MedTech News | Beta Bionics, Philips, SeeMedX","description":"Beta Bionics\u2019 iLet Bionic Pancreas; Merit Medical\u2019s Acquisition; Elixir Medical\u2019s LithiX HC-IVL System; iRhythm Technologies\u2019 Zio AT Device","robots":{"index":"index","follow":"follow","max-snippet":"max-snippet:-1","max-image-preview":"max-image-preview:large","max-video-preview":"max-video-preview:-1"},"canonical":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx","og_locale":"en_US","og_type":"article","og_title":"MedTech News | Beta Bionics, Philips, SeeMedX","og_description":"Beta Bionics\u2019 iLet Bionic Pancreas; Merit Medical\u2019s Acquisition; Elixir Medical\u2019s LithiX HC-IVL System; iRhythm Technologies\u2019 Zio AT Device","og_url":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx","og_site_name":"DelveInsight Business Research","article_publisher":"https:\/\/www.facebook.com\/DelveInsight-1423323754607782\/","article_published_time":"2024-11-07T10:58:06+00:00","article_modified_time":"2024-11-07T10:58:08+00:00","og_image":[{"width":772,"height":482,"url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/11\/07162755\/medtech-news-for-beta-bionics-philips-seemedx.png","type":"image\/png"}],"author":"Sandeep Joshi","twitter_card":"summary_large_image","twitter_creator":"@DelveInsight","twitter_site":"@DelveInsight","twitter_misc":{"Written by":"Sandeep Joshi","Est. reading time":"9 minutes"},"schema":{"@context":"https:\/\/schema.org","@graph":[{"@type":"WebPage","@id":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx","url":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx","name":"MedTech News | Beta Bionics, Philips, SeeMedX","isPartOf":{"@id":"https:\/\/www.delveinsight.com\/blog\/#website"},"primaryImageOfPage":{"@id":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx#primaryimage"},"image":{"@id":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx#primaryimage"},"thumbnailUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/11\/07162755\/medtech-news-for-beta-bionics-philips-seemedx.png","datePublished":"2024-11-07T10:58:06+00:00","dateModified":"2024-11-07T10:58:08+00:00","author":{"@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/f1eefd8dd4afdb0617d6166f8b301e0a"},"description":"Beta Bionics\u2019 iLet Bionic Pancreas; Merit Medical\u2019s Acquisition; Elixir Medical\u2019s LithiX HC-IVL System; iRhythm Technologies\u2019 Zio AT Device","inLanguage":"en-US","potentialAction":[{"@type":"ReadAction","target":["https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx"]}]},{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/medtech-news-for-beta-bionics-philips-seemedx#primaryimage","url":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/11\/07162755\/medtech-news-for-beta-bionics-philips-seemedx.png","contentUrl":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/11\/07162755\/medtech-news-for-beta-bionics-philips-seemedx.png","width":772,"height":482,"caption":"medtech-news-for-beta-bionics-philips-seemedx"},{"@type":"WebSite","@id":"https:\/\/www.delveinsight.com\/blog\/#website","url":"https:\/\/www.delveinsight.com\/blog\/","name":"DelveInsight Business Research","description":"Blog","potentialAction":[{"@type":"SearchAction","target":{"@type":"EntryPoint","urlTemplate":"https:\/\/www.delveinsight.com\/blog\/?s={search_term_string}"},"query-input":{"@type":"PropertyValueSpecification","valueRequired":true,"valueName":"search_term_string"}}],"inLanguage":"en-US"},{"@type":"Person","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/f1eefd8dd4afdb0617d6166f8b301e0a","name":"Sandeep Joshi","image":{"@type":"ImageObject","inLanguage":"en-US","@id":"https:\/\/www.delveinsight.com\/blog\/#\/schema\/person\/image\/","url":"https:\/\/secure.gravatar.com\/avatar\/7676451175fe155887a18ffb50e674b270d87436a3fc34ca206f86921cddf4cd?s=96&d=mm&r=g","contentUrl":"https:\/\/secure.gravatar.com\/avatar\/7676451175fe155887a18ffb50e674b270d87436a3fc34ca206f86921cddf4cd?s=96&d=mm&r=g","caption":"Sandeep Joshi"},"sameAs":["http:\/\/Delveinsight.com"]}]}},"author_meta":{"display_name":"Sandeep Joshi","author_link":"https:\/\/www.delveinsight.com\/blog\/author\/sjoshidelveinsight-com"},"featured_img":"https:\/\/assets.delveinsight.com\/blog\/wp-content\/uploads\/2024\/11\/07162755\/medtech-news-for-beta-bionics-philips-seemedx-300x187.png","coauthors":[],"tax_additional":{"categories":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Notizia - Recent Pharma, Healthcare and Biotech Happenings<\/span>"]},"tags":{"linked":["<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Atherectomy Devices<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Cardiac monitoring devices<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">ECG Telemetry Devices<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Electrophysiology Devices<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Insulin Delivery Devices<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Lithotripsy Devices<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">Medical Devices Market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">MedTech Market<\/a>","<a href=\"https:\/\/www.delveinsight.com\/blog\/notizia\/\" class=\"advgb-post-tax-term\">recent pharma news<\/a>"],"unlinked":["<span class=\"advgb-post-tax-term\">Atherectomy Devices<\/span>","<span class=\"advgb-post-tax-term\">Cardiac monitoring devices<\/span>","<span class=\"advgb-post-tax-term\">ECG Telemetry Devices<\/span>","<span class=\"advgb-post-tax-term\">Electrophysiology Devices<\/span>","<span class=\"advgb-post-tax-term\">Insulin Delivery Devices<\/span>","<span class=\"advgb-post-tax-term\">Lithotripsy Devices<\/span>","<span class=\"advgb-post-tax-term\">Medical Devices Market<\/span>","<span class=\"advgb-post-tax-term\">MedTech Market<\/span>","<span class=\"advgb-post-tax-term\">recent pharma news<\/span>"]}},"comment_count":"0","relative_dates":{"created":"Posted 2 years ago","modified":"Updated 2 years ago"},"absolute_dates":{"created":"Posted on Nov 7, 2024","modified":"Updated on Nov 7, 2024"},"absolute_dates_time":{"created":"Posted on Nov 7, 2024 4:28 pm","modified":"Updated on Nov 7, 2024 4:28 pm"},"featured_img_caption":"medtech-news-for-beta-bionics-philips-seemedx","series_order":"","_links":{"self":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/30255","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/users\/14"}],"replies":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/comments?post=30255"}],"version-history":[{"count":1,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/30255\/revisions"}],"predecessor-version":[{"id":30256,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/posts\/30255\/revisions\/30256"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media\/30263"}],"wp:attachment":[{"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/media?parent=30255"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/categories?post=30255"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/tags?post=30255"},{"taxonomy":"industry","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/industry?post=30255"},{"taxonomy":"therapeutic_areas","embeddable":true,"href":"https:\/\/www.delveinsight.com\/blog\/wp-json\/wp\/v2\/therapeutic_areas?post=30255"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}