{"id":35372,"date":"2026-06-05T10:29:26","date_gmt":"2026-06-05T04:59:26","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=35372"},"modified":"2026-06-05T14:10:53","modified_gmt":"2026-06-05T08:40:53","slug":"orthalign-zepto-precision-leica-shiratonics-implantica-medtech-2026","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/orthalign-zepto-precision-leica-shiratonics-implantica-medtech-2026","title":{"rendered":"OrthAlign FDA Clearance for Lantern ASC System, Zepto Life FDA Breakthrough Designation, Precision Spine Launch, Leica Biosystems AI Expansion, ShiraTronics Trial Milestone &amp; Implantica GERD Cost-Effectiveness Study Drive Major MedTech Innovation Advances"},"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-6a22c00e50c83\" 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-6a22c00e50c83\"  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\/orthalign-zepto-precision-leica-shiratonics-implantica-medtech-2026\/#OrthAlign_Inc_Received_FDA_510k_clearance_for_the_Lantern%C2%AE_ASC_system\" >OrthAlign, Inc. Received FDA 510(k) clearance for the Lantern\u00ae ASC system<\/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\/orthalign-zepto-precision-leica-shiratonics-implantica-medtech-2026\/#Zepto_Life_Technology_Received_FDA_Breakthrough_Device_Designation_for_Targeted_Liquid_Biopsy_Test_for_Invasive_Mold_Infections\" >Zepto Life Technology Received FDA Breakthrough Device Designation for Targeted Liquid Biopsy Test for Invasive Mold Infections<\/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\/orthalign-zepto-precision-leica-shiratonics-implantica-medtech-2026\/#Precision_Spine%C2%AE_Launched_Reform%C2%AE_Ti_FS_Modular_Fenestrated_Screw_System\" >Precision Spine\u00ae Launched Reform\u00ae Ti FS Modular Fenestrated Screw System<\/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\/orthalign-zepto-precision-leica-shiratonics-implantica-medtech-2026\/#Leica_Biosystems_Announced_Expansion_of_Collaboration_to_Scale_Precision_Medicine_and_Develop_AI-Powered_Diagnostics\" >Leica Biosystems Announced Expansion of Collaboration to Scale Precision Medicine and Develop AI-Powered Diagnostics<\/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\/orthalign-zepto-precision-leica-shiratonics-implantica-medtech-2026\/#ShiraTronics_Completed_Enrollment_in_RELIEV-CM2_Pivotal_Trial_of_Implantable_Extracranial_Neuromodulation_Systems_IENs_for_Chronic_Migraine\" >ShiraTronics Completed Enrollment in RELIEV-CM2 Pivotal Trial of Implantable Extracranial Neuromodulation Systems (IENs) for Chronic Migraine<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-2'><a class=\"ez-toc-link ez-toc-heading-6\" href=\"https:\/\/www.delveinsight.com\/blog\/orthalign-zepto-precision-leica-shiratonics-implantica-medtech-2026\/#Implantica_Announced_Publication_of_a_New_Health_Economics_Study_Showing_Refluxstop%C2%AES_Superior_Cost-Effectiveness_in_the_Treatment_of_GERD_in_the_Italian_Healthcare_System\" >Implantica Announced Publication of a New Health Economics Study Showing Refluxstop\u00ae&#8217;S Superior Cost-Effectiveness in the Treatment of GERD in the Italian Healthcare System<\/a><\/li><\/ul><\/nav><\/div>\n\n<h2 class=\"wp-block-heading\" id=\"h-orthalign-inc-received-fda-510-k-clearance-for-the-lantern-asc-system\"><span class=\"ez-toc-section\" id=\"OrthAlign_Inc_Received_FDA_510k_clearance_for_the_Lantern%C2%AE_ASC_system\"><\/span><strong>OrthAlign, Inc. Received FDA 510(k) clearance for the Lantern\u00ae ASC system<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On <strong>03 June 2026<\/strong>, OrthAlign, Inc., a developer of handheld orthopedic navigation technologies, announced that it had received FDA 510(k) clearance for its Lantern ASC system, a navigation solution designed to provide the accuracy of advanced surgical technologies while reducing the cost and operational complexity typically associated with robotic platforms. The launch came as ambulatory surgery centers (ASCs) continued to emerge as one of the fastest-growing segments within the orthopedic surgery market, creating increasing demand for efficient and cost-effective surgical technologies.<\/p>\n\n\n\n<p>The Lantern ASC system was developed specifically to address the practical needs of ASCs by eliminating many of the barriers commonly associated with robotic-assisted surgery, including high capital investment requirements, extensive operating room setup times, and complex training processes. The system combined a reusable navigation device with a procedure-specific Smart Pack Kit, enabling surgeons to access real-time navigation guidance during total knee arthroplasty, partial knee replacement, and gap balancing procedures in both primary and revision cases.<\/p>\n\n\n\n<p>Designed to be portable, scalable, and easy to implement, Lantern ASC integrated seamlessly with existing Lantern instrumentation and was compatible with a wide range of implant systems. The technology was intended to help ASCs improve surgical precision while maintaining operational efficiency and controlling procedural costs.<\/p>\n\n\n\n<p>OrthAlign noted that the Lantern ASC platform was built upon the clinical experience gained from more than 450,000 procedures performed using the company\u2019s navigation technologies. As ambulatory surgery centers continued to perform a growing share of joint replacement procedures, the company positioned Lantern ASC as a solution capable of supporting both high-quality patient outcomes and financial sustainability. Through the FDA clearance of Lantern ASC, OrthAlign further strengthened its position in the orthopedic navigation market and expanded access to advanced navigation technology for a broader range of surgical facilities.<\/p>\n\n\n\n<p><em>&#8220;As total joint arthroplasty shifts to the ASC and patients seek technology for their knee or hip replacements, surgeons and administrators need a smart solution, both clinically and economically,&#8221; <\/em>said Eric Timko, CEO of OrthAlign. <em>&#8220;We engineered Lantern ASC to be a technology that leaves no stakeholder behind. Surgeons get accuracy and reliability, patients get the outcomes they came for, and the business gets a leading technology that works for the bottom line. Unlike technologies that burden a center&#8217;s finances and throttle OR efficiency, Lantern ASC improves throughput, maintains or beats manual procedure times, and makes advanced navigation something that meets the needs of the entire ASC ecosystem.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s<strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/ambulatory-surgical-centers-market\" class=\"ek-link\"><strong>Ambulatory Surgical Centers<\/strong><\/a> <strong>&#8211; Market Insights, Competitive Landscape, and Market Forecast \u2013 2030,\u201d<\/strong> the global ambulatory surgical centers market is poised for significant growth, projected to achieve a remarkable CAGR of <strong>5.77%<\/strong> during the forecast period from 2024 to 2030. This robust market expansion can be attributed to various factors that underscore the increasing demand for multispecialty ambulatory surgical centers. One key driving force behind this upward trajectory is the escalating preference for ambulatory surgical centers over traditional hospital settings. The inherent advantage of lower expenditure associated with ambulatory centers compared to hospitals has become a pivotal factor influencing patient choices. This cost-effectiveness, coupled with favorable reimbursement scenarios, is expected to contribute substantially to the burgeoning market. Moreover, the heightened awareness of the reduction in the risk of infections in ambulatory surgical centers serves as an additional catalyst for market growth. Patients are increasingly recognizing the benefits of undergoing surgical procedures in these centers, where the controlled environment minimizes the risk of infections, thereby ensuring a safer healthcare experience. In conclusion, the ambulatory surgical centers market is on a trajectory of substantial growth during the forecast period. The confluence of factors such as cost-effectiveness, favorable reimbursement scenarios, reduced infection risks, and the emergence of multispecialty centers positions ambulatory surgical centers as a vital component of the evolving healthcare landscape, contributing significantly to the overall improvement of patient care and experience.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-zepto-life-technology-received-fda-breakthrough-device-designation-for-targeted-liquid-biopsy-test-for-invasive-mold-infections\"><span class=\"ez-toc-section\" id=\"Zepto_Life_Technology_Received_FDA_Breakthrough_Device_Designation_for_Targeted_Liquid_Biopsy_Test_for_Invasive_Mold_Infections\"><\/span><strong>Zepto Life Technology Received FDA Breakthrough Device Designation for Targeted Liquid Biopsy Test for Invasive Mold Infections<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On <strong>03 June 2026<\/strong>, Zepto Life Technology announced that the U.S. Food and Drug Administration (FDA) had granted Breakthrough Device Designation to its FungiFlex\u00ae Mold Panel, a liquid biopsy-based diagnostic test developed to support the detection and identification of invasive mold infections through the analysis of fungal cell-free DNA (cfDNA) in patient plasma samples.<\/p>\n\n\n\n<p>At the time of the announcement, the FungiFlex\u00ae Mold Panel was being offered as a Laboratory Developed Test (LDT) through Zepto Life Technology\u2019s CLIA-certified laboratory and was available for physician ordering. The test was designed to address a major clinical challenge in the diagnosis of invasive mold infections, which are associated with high rates of morbidity and mortality, particularly among immunocompromised patients. Traditional diagnostic methods often relied on a combination of imaging studies, microbiological testing, histopathology, and serological assessments, making rapid and accurate organism-level identification difficult.<\/p>\n\n\n\n<p>The FungiFlex\u00ae Mold Panel utilized liquid biopsy technology to detect fungal cfDNA circulating in the bloodstream and identify several clinically significant mold pathogens, including Aspergillus, Mucorales, Fusarium, and Scedosporium\/Lomentospora species. By enabling direct pathogen identification from plasma samples, the test aimed to overcome limitations associated with conventional diagnostic approaches and provide physicians with earlier and more precise diagnostic information when invasive mold infection was suspected.<\/p>\n\n\n\n<p>The FDA\u2019s Breakthrough Device Designation acknowledged the potential of the FungiFlex\u00ae Mold Panel to improve the diagnosis of life-threatening fungal infections and address a significant unmet clinical need. The designation was expected to facilitate a more streamlined development and regulatory review process, supporting faster access to innovative diagnostic technologies for patients at high risk of invasive mold diseases.<\/p>\n\n\n\n<p><em>&#8220;One of the most frustrating realities in invasive fungal infections is that clinicians are often forced to make critical treatment decisions without knowing exactly which organism is causing disease,&#8221; <\/em>said Hannah Zhang, Chief Executive Officer of Zepto Life Technology.<em> &#8220;Our goal has always been to provide actionable organism-level information from a simple plasma sample. We believe targeted liquid biopsy testing has the potential to fundamentally change how these infections are diagnosed.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s <strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/liquid-biopsy-in-cancer-diagnostics-market\"><strong>Liquid Biopsy in Cancer Diagnostics<\/strong><\/a> <strong>&#8211; Market Insights, Competitive Landscape, and Market Forecast \u2013 2032,\u201d<\/strong> the global liquid biopsy in cancer diagnostics market was valued at <strong>USD 7.64 billion<\/strong> in 2024, growing at a <strong>CAGR<\/strong> of <strong>16.64%<\/strong> during the forecast period from 2025 to 2032 to reach <strong>USD 19.24 billion<\/strong> by 2034. Factors such as the rising incidence of various cancers, growing demand for minimally invasive procedures, increasing demand for precision medicine, and technical innovation in product development, among other factors, are expected to drive the liquid biopsy in cancer diagnostics market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-precision-spine-launched-reform-ti-fs-modular-fenestrated-screw-system\"><span class=\"ez-toc-section\" id=\"Precision_Spine%C2%AE_Launched_Reform%C2%AE_Ti_FS_Modular_Fenestrated_Screw_System\"><\/span><strong>Precision Spine\u00ae Launched Reform\u00ae Ti FS Modular Fenestrated Screw System<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On <strong>03 June 2026<\/strong>, Precision Spine, Inc., a U.S.-based medical device manufacturer, announced the launch of its Reform\u00ae Ti FS Modular Fenestrated Screw System, a specialized pedicle screw system designed to provide cement augmentation in challenging spinal fusion cases. The system was developed to enhance fixation in patients with osteoporotic bone, spinal tumors, and other conditions where traditional pedicle screws may be at risk of loosening or pullout due to poor bone quality.<\/p>\n\n\n\n<p>The Reform\u00ae Ti FS system delivered PMMA bone cement directly into the vertebral body through the screw shaft. Its design incorporated three fenestrations positioned 120 degrees apart around the screw shaft, enabling uniform cement distribution and improved anchorage. The modular tulip configuration also allowed compatibility with Precision Spine\u2019s existing Reform\u00ae Ti and Reform\u00ae Ti MIS CT spinal fixation systems.<\/p>\n\n\n\n<p>The Reform Pedicle Screw System was intended to provide spinal stabilization and immobilization as an adjunct to fusion in skeletally mature patients suffering from conditions such as degenerative disc disease, spondylolisthesis, spinal trauma, spinal stenosis, scoliosis, kyphosis, lordosis, spinal tumors, pseudarthrosis, and failed previous spinal fusion procedures.<\/p>\n\n\n\n<p>The system was also indicated for use in pediatric patients undergoing treatment for adolescent idiopathic scoliosis when utilized for posterior non-cervical pedicle screw fixation as an adjunct to fusion. Additionally, when used with compatible bone cement products, the fenestrated pedicle screws were intended to provide temporary spinal stabilization in patients with advanced-stage thoracic, lumbar, or sacral spinal tumors whose life expectancy was insufficient to allow successful spinal fusion. This expanded the clinical utility of the system in oncology-related spinal procedures and complex reconstructive surgeries.<\/p>\n\n\n\n<p>Chris DeNicola, President and CEO of Precision Spine Inc., stated,<em> &#8220;This addition to our Reform family of products broadens the breadth of indications that can be addressed by offering surgeons the ability to provide stabilization in compromised bone while still utilizing the advanced features of the Reform Ti System.&#8221;<\/em><\/p>\n\n\n\n<p>As per DelveInsight\u2019s<strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/spinal-implants-market\"><strong>Spinal Implants<\/strong><\/a> <strong>&#8211; Market Insights, Competitive Landscape, and Market Forecast \u2013 2032,\u201d<\/strong> the global spinal implants market was valued at <strong>USD 14,324.12 million<\/strong> in 2024, growing at a <strong>CAGR<\/strong> of <strong>5.50%<\/strong> during the forecast period from 2025 to 2032 to reach <strong>USD 21,899.24 million<\/strong> by 2032. The rising cases of spinal disorders, particularly among aging populations, have significantly increased the demand for corrective surgical interventions. Simultaneously, the surge in sports-related and accident-induced spinal injuries is fueling the need for advanced implantable solutions. Moreover, there is a growing preference for non-fusion and motion preservation devices that maintain spinal mobility and enhance patient outcomes, especially among younger and more active individuals. Coupled with this is the uptick in product development activities and technological innovations by key market players globally, which is expanding the range of available solutions and improving surgical success rates. Together, these trends are accelerating the adoption of Spinal Implants and driving the overall market during the forecast period from 2025 to 2032.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-leica-biosystems-announced-expansion-of-collaboration-to-scale-precision-medicine-and-develop-ai-powered-diagnostics\"><span class=\"ez-toc-section\" id=\"Leica_Biosystems_Announced_Expansion_of_Collaboration_to_Scale_Precision_Medicine_and_Develop_AI-Powered_Diagnostics\"><\/span><strong>Leica Biosystems Announced Expansion of Collaboration to Scale Precision Medicine and Develop AI-Powered Diagnostics <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On <strong>03 June 2026<\/strong>, Leica Biosystems, a subsidiary of Danaher and a global provider of anatomic and digital pathology solutions, announced the expansion of its strategic collaboration with AstraZeneca and Daiichi Sankyo to develop an immunohistochemistry (IHC) assay and image analysis algorithm targeting the TROP2 Normalized Membrane Ratio (NMR) biomarker in non-small cell lung cancer (NSCLC). The assay and algorithm were intended for research use only and aimed to support the evaluation of novel biomarker-driven approaches in oncology.<\/p>\n\n\n\n<p>The expanded collaboration was built upon an agreement initially announced in May 2025 and utilized AstraZeneca\u2019s proprietary Quantitative Continuous Scoring (QCS) computational pathology algorithm in combination with Leica Biosystems\u2019 expertise in digital pathology and IHC assay development. Together, the companies sought to create an integrated end-to-end solution capable of assessing the TROP2 NMR biomarker by analyzing both membrane and cytoplasmic protein expression, providing a more comprehensive evaluation than traditional biomarker assessment methods.<\/p>\n\n\n\n<p>The initiative represented a significant advancement in the application of digital pathology, computational pathology, and artificial intelligence-assisted image analysis. By leveraging advanced algorithms, the collaborators aimed to improve diagnostic precision and support the identification of patients who may be more likely to benefit from targeted cancer therapies. The project also reflected the broader industry trend toward digital pathology workflows, driven by increasing adoption of whole-slide imaging, digital slide management platforms, and AI-enabled diagnostic tools.<\/p>\n\n\n\n<p>To support development and deployment of the solution, the collaboration utilized several Leica Biosystems technologies, including the BOND RX research stainer, BOND-III clinical stainer, Aperio GT 450 scanner, and the Aperio HALO AP image management system. These platforms enabled the rapid generation, analysis, and management of pathology images while facilitating the development of advanced computational pathology algorithms.<\/p>\n\n\n\n<p>Upon completion, the TROP2 NMR algorithm was planned to be made available through the Aperio AI Store, Leica Biosystems\u2019 open marketplace for artificial intelligence and image analysis applications. This would allow researchers and pathology laboratories to access, evaluate, and deploy the algorithm within a unified digital pathology ecosystem, further supporting the integration of computational pathology tools into cancer research and precision medicine initiatives.<\/p>\n\n\n\n<p><em>&#8220;Advancing cancer diagnostics requires more than individual innovations; it demands collaboration across science, technology, and workflow,&#8221; <\/em>said Gustavo Perez-Fernandez, Group Executive, Diagnostics, at Danaher and President of Leica Biosystems.<em> &#8220;By working alongside AstraZeneca and Daiichi Sankyo, we are bringing together complementary expertise to help address some of the most complex challenges in biomarker research, to enable more precise and scalable approaches that support the future of precision medicine.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s <strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/ai-in-precision-medicine-market\"><strong>Artificial Intelligence in Precision Medicines<\/strong><\/a><strong> &#8211; <\/strong><strong>Global Market Insights, Competitive Landscape, and Market Forecast &#8211; 2034<\/strong><strong>\u201d<\/strong>, the global artificial intelligence in precision medicines market size is expected to increase from <strong>USD 1,371.70 million<\/strong> in 2025 to <strong>USD 18,071.56 million<\/strong> by 2034, growing at a <strong>CAGR <\/strong>of <strong>33.26%<\/strong> during the forecast period from 2026 to 2034. The rising prevalence of chronic and genetic diseases is significantly increasing the need for more accurate, early, and individualized treatment approaches, which is driving the adoption of artificial intelligence (AI) in precision medicine. At the same time, the growing demand for personalized therapies and precision diagnostics is encouraging healthcare providers and researchers to leverage AI for analyzing complex genomic, clinical, and real-world data to tailor treatments for individual patients. Additionally, increasing global product development activities, particularly in drug discovery, biomarker identification, and companion diagnostics, are further accelerating the integration of AI technologies. Collectively, these factors are boosting the AI in the precision medicine market by enhancing efficiency, reducing development timelines, and improving clinical outcomes.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-shiratronics-completed-enrollment-in-reliev-cm2-pivotal-trial-of-implantable-extracranial-neuromodulation-systems-iens-for-chronic-migraine\"><span class=\"ez-toc-section\" id=\"ShiraTronics_Completed_Enrollment_in_RELIEV-CM2_Pivotal_Trial_of_Implantable_Extracranial_Neuromodulation_Systems_IENs_for_Chronic_Migraine\"><\/span><strong>ShiraTronics Completed Enrollment in RELIEV-CM2 Pivotal Trial of Implantable Extracranial Neuromodulation Systems (IENs) for Chronic Migraine <\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On <strong>02 June 2026<\/strong>, ShiraTronics, Inc., a clinical-stage medical device company focused on developing neuromodulation therapies for chronic migraine, announced the completion of patient enrollment in its RELIEV-CM2 pivotal clinical trial and the acceptance of a dedicated five-code Category III CPT code set by the American Medical Association (AMA) for bilateral supraorbital-occipital neurostimulator services. Together, these milestones reflected increasing recognition of Implantable Extracranial Neuromodulation Systems (IENs), an emerging category of therapies designed specifically for chronic migraine management.<\/p>\n\n\n\n<p>The RELIEV-CM2 study was a prospective, multicenter, double-blind, randomized Investigational Device Exemption (IDE) trial designed to evaluate the safety and effectiveness of the ShiraTronics implantable neurostimulation system in adults suffering from chronic migraine. Conducted across 28 clinical sites in the United States and Australia, the study successfully enrolled 300 participants within approximately 18 months. All participating centers enrolled and implanted patients, demonstrating strong interest from both physicians and patients despite the historical challenges associated with recruiting chronic migraine patients for clinical trials. By the completion of enrollment, 146 participants had received the investigational implant.<\/p>\n\n\n\n<p>The achievement built upon encouraging results from the earlier RELIEV-CM Pilot Study, which had demonstrated sustained reductions in monthly headache days over 12 months, along with improvements in migraine-related quality of life and a favorable safety profile without unexpected adverse events.<\/p>\n\n\n\n<p>In a separate milestone, the AMA CPT Editorial Panel accepted five new Category III CPT codes for bilateral supraorbital-occipital neurostimulator procedures, with implementation scheduled for January 1, 2027. Although Category III codes do not establish reimbursement or guarantee insurance coverage, their acceptance signified formal recognition of the procedure as a distinct and emerging clinical service. The coding decision represented an important step in establishing the clinical and reimbursement framework necessary for future adoption of implantable migraine therapies.<\/p>\n\n\n\n<p>The investigational ShiraTronics system was developed as a fully implantable neurostimulator specifically designed for chronic migraine treatment. The device delivered targeted neurostimulation to the trigeminal nerve complex, a key neurological pathway involved in migraine pathophysiology. Unlike many existing therapies that relied on medications or externally worn devices, the ShiraTronics system was designed to provide continuous, around-the-clock therapy without requiring external hardware or active patient management after implantation.<\/p>\n\n\n\n<p>The company stated that these achievements supported its long-term vision of providing patients with a purpose-built implantable treatment option for chronic migraine while simultaneously advancing the necessary clinical, regulatory, and reimbursement infrastructure. Following the completion of pivotal trial enrollment, ShiraTronics planned to proceed with data readouts and pursue FDA Premarket Approval (PMA). The company, which had previously received FDA Breakthrough Device Designation in 2021 and secured approximately $108 million in funding, indicated that a limited commercial launch could follow successful clinical outcomes and regulatory review.<\/p>\n\n\n\n<p>According to DelveInsight\u2019s \u201d<a href=\"https:\/\/www.delveinsight.com\/report-store\/neuromodulation-devices-market\"><strong>Neuromodulation Devices<\/strong><\/a> &#8211; <strong>Market Insights, Competitive Landscape, and Market Forecast-2032<\/strong>,\u201d the global neuromodulation devices market is expected to increase from <strong>USD 7,862.04 million<\/strong> in 2024 to <strong>USD 16,111.10 million<\/strong> by 2032, growing at a CAGR of <strong>9.44%<\/strong> during the forecast period from 2025 to 2032. The market for neuromodulation devices is growing rapidly, fueled by the rising global prevalence of chronic diseases like pain, epilepsy, and depression. This growth is also driven by significant technological advancements that have made devices smaller, smarter, and more effective. Favorable regulatory policies and better reimbursement coverage are also making these treatments more accessible. Overall, the increasing demand for effective, long-term therapeutic options for neurological and chronic conditions is creating a strong and sustained market.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\" id=\"h-implantica-announced-publication-of-a-new-health-economics-study-showing-refluxstop-s-superior-cost-effectiveness-in-the-treatment-of-gerd-in-the-italian-healthcare-system\"><span class=\"ez-toc-section\" id=\"Implantica_Announced_Publication_of_a_New_Health_Economics_Study_Showing_Refluxstop%C2%AES_Superior_Cost-Effectiveness_in_the_Treatment_of_GERD_in_the_Italian_Healthcare_System\"><\/span><strong>Implantica Announced Publication of a New Health Economics Study Showing Refluxstop\u00ae&#8217;S Superior Cost-Effectiveness in the Treatment of GERD in the Italian Healthcare System<\/strong><span class=\"ez-toc-section-end\"><\/span><\/h2>\n\n\n\n<p>On <strong>21 May 2026<\/strong>, Implantica AG announced that a new study had demonstrated that its innovative GERD treatment device, RefluxStop, was highly cost-effective compared to conventional GERD treatments within the Italian healthcare system. The study, titled \u201cCost-effectiveness of RefluxStop for gastroesophageal reflux disease: analysis from an Italian healthcare perspective,\u201d was conducted by the York Health Economics Consortium in collaboration with leading Italian anti-reflux surgeons and was published in BMC Gastroenterology.<\/p>\n\n\n\n<p>The health-economic analysis showed that RefluxStop\u00ae had a 100% probability of being cost-effective compared with proton pump inhibitors (PPIs) and magnetic sphincter augmentation (MSA), along with a 97% probability compared with Nissen fundoplication in Italy\u2019s healthcare system. The company also reported that more than 200 procedures had already been completed, while increasing approvals of public tenders across Italy had strengthened the commercial adoption of RefluxStop\u00ae. The positive reimbursement outlook in Italy was expected to support wider adoption across other European healthcare markets as well.<\/p>\n\n\n\n<p>Inventor of RefluxStop\u00ae and CEO of Implantica, Dr. Peter Forsell says,<em> &#8220;The basis for a successful launch of a new treatment always depends on good or superior clinical results; however, the power of having the most cost-effective treatment should not be underestimated. Italy is a good example where health economics, with RefluxStop being the most cost-effective treatment available, goes hand in hand with securing procurement in the public healthcare system. We are grateful to the independent surgeons who choose to collect and publish RefluxStop\u00ae data, driving surgical innovation forward for GERD patients everywhere.&#8221;<\/em><\/p>\n\n\n\n<p>According to DelveInsight\u2019s <strong>\u201c<\/strong><a href=\"https:\/\/www.delveinsight.com\/report-store\/gastroesophageal-reflux-disease-gerd-treatment-devices-market\"><strong>Gastroesophageal Reflux Disease (GERD) Devices<\/strong><\/a> <strong>&#8211; Market Insights, Competitive Landscape, and Market Forecast \u2013 2030,\u201d <\/strong>the global gastroesophageal reflux disease (GERD) devices market is estimated to grow at a <strong>CAGR<\/strong> of <strong>9.20%<\/strong> during the forecast period. The demand for gastroesophageal reflux disease (GERD) devices is primarily being boosted by the rising number of patients suffering from obesity owing to the sedentary lifestyle, increasing technological advancements associated with the GERD devices, and the rising geriatric population susceptible to developing the GERD disorder, contributing to the overall market growth of the gastroesophageal reflux disease (GERD) Devices during the forecast period from 2024 to 2030.<\/p>\n\n\n\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>OrthAlign, Inc. Received FDA 510(k) clearance for the Lantern\u00ae ASC system On 03 June 2026, OrthAlign, Inc., a developer of handheld orthopedic navigation technologies, announced that it had received FDA 510(k) clearance for its Lantern ASC system, a navigation solution designed to provide the accuracy of advanced surgical technologies while reducing the cost and operational [&hellip;]<\/p>\n","protected":false},"author":14,"featured_media":35373,"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":[23014,23012,23011,23010,23013,23009],"industry":[17226],"therapeutic_areas":[17239,17231,17245,17228],"class_list":["post-35372","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-implantica-gerd-study","tag-leica-biosystems-ai-expansion","tag-orthalign-fda-clearance","tag-precision-spine-launch","tag-shiratronics-clinical-trial","tag-zepto-life-breakthrough-designation","industry-medical-devices","therapeutic_areas-gastroenterology","therapeutic_areas-infectious-diseases","therapeutic_areas-neurology","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- 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